Job Opportunities

 General Information:

• Job Title: Senior Quality Assurance Associate
• Company:  Corgenix Inc, Broomfield, CO
• Department: Quality and Regulatory Affairs
• Reports to: Director, Quality and Regulatory Affairs
• GENERAL PURPOSE: Oversees Quality Assurance activities to ensure compliance with regulatory agencies, ISO, and Corgenix requirements.

KEY RESPONSIBILITIES:

• Final disposition authority for incoming materials, including packaging and labeling, used in product manufacturing.
• Manage the Approved Vendor List and vendor system, perform supplier audits.
• Review and final approval authority for device history records.
• Develop quality assurance policies, procedures, instructions, and records in accordance with current regulatory requirements. Present and activate such policies, as approved by management.
• Assist in establishing document approval and change control procedures. Assist with document control procedures, as necessary.
• Assist personnel in developing procedures, instructions, test methods, and records, as requested.
• Assist the Director of Quality and Regulatory Affairs in scheduling, initiating, and performing departmental audits of systems and processes.
• Final review and approval signature on validation studies.
• Responsible for employee quality system training in accordance with regulatory requirements (QSR and ISO). This includes presenting initial QSR training for all new employees and developing annual company update training for all employees. Furthermore, this position is responsible for designing and assisting in all Quality Assurance related training.
• Manage CAPA program to ensure timely completion of each CAPA phase and ensure the effectiveness of CAPAs.
• Oversee coordination and maintenance of company quality training program files.
• Final review and sign off approval for new documents/new document revisions prior to distribution.
• Assist in FDA and ISO inspections, follow-up actions, and correspondence regarding compliance issues.
• Assist the Director of Quality and Regulatory Affairs in the development and execution of Quality Department operational and strategic programs including work plans, short and long range goals, audit requirements, training needs, and budgets.
• Manage filing and database inputs of quality documents (e.g. process validations, equipment validations, Action Impact Reviews, packaging and transport testing).
• Contribute to Quality Forum newsletters, conduct training, and perform other activities to educate employees on quality concepts.
• Final review and sign off of final product.
• Other duties as assigned by Supervisor.

CONTACTS

• INSIDE COMPANY: Works closely with Quality Control, Document Control, Manufacturing, Marketing, Regulatory Affairs, and R&D.
• OUTSIDE COMPANY: Raw material suppliers concerning quality and compliance issues. FDA and ISO regarding compliance issues.

JOB TITLE DIRECTLY SUPERVISED: N/A

WORKING CONDITIONS

• This position primarily functions in a typical office environment.
• Due to the interaction with Quality Control, this position will occasionally function in a laboratory setting with risk of exposure to biological and chemical hazards associated with such a setting.
• The position requires a moderate level of mental exertion, with the individual having to respond to short deadlines and crises.
• The position may require in excess of forty hours per week and generate a moderate amount of stress.

SPECIALIZED EQUIPMENT USED:

• General office equipment including personal computer hardware, standard computer software (e.g., word processing, spread sheets, database, statistical programs), copiers, Fax machines, paper shredder, paper binding equipment, and printers.

ACCOUNTABILITY/SCOPE OF THE POSITION:

• This position is accountable for the Quality Assurance activities of the company.
• It is a highly visible position, integral to the Company’s short and long term success.
• This position is key to the long and short term success of the company and requires a high level of commitment to the goals set by the Quality and Regulatory Affairs Department and the company.

BACKGROUND KNOWLEDGE:

• A Bachelors Degree is required along with a working knowledge of Quality Assurance principles and methods.

EXPERIENCE:

• This position requires a minimum of 6 years working experience in a Quality Assurance role within an FDA regulated environment (Medical Device industry preferred).
• Knowledge of the FDA Quality System Regulation and ISO13485 is strongly preferred.

GENERAL:

• This person must demonstrate the ability to work and think independently and possess excellent written and oral communication skills.
• Qualified candidates should send resume and cover letter to dfsimpson@corgenix.com

General Information:

University of Colorado’s School of Medicine

Position: Director of Quality

About the Company:

The Gates Biomanufacturing Facility will be established as an auxiliary service center of the University of Colorado’s School of Medicine, Department of Dermatology and the Charles C. Gates Center for Regenerative Medicine and Stem Cell Biology

Job Description:

• The Gates Biomanufacturing Facility is seeking a qualified candidate that will be responsible for directing quality assurance and quality control (QA/QC) for the Facility.
• The Director of Quality will plan and establish QA/QC policies, programs, systems and initiatives.
• In addition, the selected candidate will establish testing methods and systems to ensure quality standards and specifications are met.

Requirements:

• Examples of Work Performed
  • Design, establish, and manage QA/QC policies, programs and systems.
  • Review and approval of all products and materials for release.
  • Participate in the preparation of CMC section for a biological product IND.
  • Establish positive relationships with internal and external members of the Gates Center community as well as users of the manufacturing facility.
• Knowledge, Skills, and Abilities
  • Master’s Degree or equivalent experience in a life sciences discipline.
  • Significant industrial experience in QA/QC.
  • Strong knowledge of cGMP/cGTP regulations and industry standards.
  • Familiar with the preparation and development of CMC section for a biological product IND.
  • Experience with working in a biotech startup environment.
  • A team-oriented, self-starter capable of operating independently.
  • Effective interpersonal communication skills.
• Minimum Requirements
  • Master’s Degree or equivalent experience in a life sciences discipline.
  • At least 10 years of industrial biotech experience in a QA/QC role.
  • A team-oriented, self-starter capable of operating independently.
• Preferred Qualifications
  • Experience working for biotech companies is a plus.
  • Experience working in a cGMP manufacturing setting is desired.
• Application Information:
  • All applications must be submitted electronically at www.jobsatcu.com, refer to job posting RF01234.
  • The jobsatcu.com employment board has this position listed as a Research Instructor.

Required Application Materials:

• When applying at www.jobsatcu.com, applicants must include:
  • A letter of application which specifically addresses the job requirements and outlines qualifications.
  • A current CV/Resume.
  • The names, addresses, daytime telephone numbers and e-mail addresses for three professional references.

More information

• Review of applications will continue until the position is filled.
• Salary is commensurate with skills and experience.
• The University of Colorado offers a full benefits package.
• Information on University benefits programs, including eligibility, is located at http://www.cu.edu/pbs/
• Please be advised that the University does check references as part of the employment process.

 

General Information:

• Company: Terumo BCT
• JOB TITLE: Sr. Regulatory Affairs Specialist
• Job Requisition: JB-1970
• Working without significant direction, provides leadership to the Company in fulfilling regulatory compliance by applying a thorough understanding of regulatory/standards requirements to one or more areas of expertise such as FDA regulations, international medical device regulations, product reimbursement, product liability, and standards.

ESSENTIAL DUTIES

• Assumes major responsibility for one or more major regulatory affairs areas based on past experience and a broad base of knowledge and understanding of regulatory requirements.
• Interacts with and/or directs others in interacting with regulatory and certification authorities. Identifies the need for, prepares, and conducts regulatory related training for the business.
• Identifies and defines contents for regulatory submissions/dossiers. Leads the assembly and creation of these documents for their timely submission to regulatory authorities.
• Advises business management of regulatory and certification issues in a pro-active manner.
• Exercises considerable judgment in determining approach and then researches, prepares, and submits required regulatory documents including those in response to documents issued by regulatory authorities. Responsibility includes both preparation of these documents in compliance with U.S. and international regulatory authorities and providing guidance to Regulatory staff in the preparation of them.
• Provides regulatory support of clinical trials.

MINIMUM QUALIFICATION REQUIREMENTS

• Education: Bachelor’s degree or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
• Experience: Minimum 5 years experience.
• Skills
  • Pharmaceutical, or medical device regulatory experience desired.
  • Familiarity with developing IDE, IND, NDA, ANDA 510(k) or PMA US FDA applications desired.
  • Experience with design control systems and project team experience a plus.
  • Knowledge and use of relevant PC software applications and skills to use them effectively.
  • Demonstrated ability to communicate effectively both verbally and in writing.
  • In depth knowledge of U.S. and/or international medical device regulations and standards.
  • Extensive knowledge of and ability to prepare regulatory documentation.
  • Proven effective leadership and team skills. Strong interpersonal skills.
  • Demonstrated ability to define problems and provide guidance to management in developing and implementing solutions.
  • Analytical and creative thinking skills and the ability to solve complex problems.
  • -Or- An equivalent competency level acquired through a variation of these qualifications may be considered.

PHYSICAL REQUIREMENTS

• Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.
• The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

EEOC and drug-free workplace:

• We are proud to be an Equal Opportunity Affirmative Action Employer.
• All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.
• We maintain a drug-free workplace and perform pre-employment substance abuse testing and background verification checks.

Apply and More information

• For more information about Terumo BCT and to apply, visit our careers website http://www.terumobct.com/careers.
• Go to the careers section and apply to requisition JB-1970

General Information:

• Company: Rocky Mountain Eye Bank http://www.corneas.org
• JOB TITLE: Quality Assurance Coordinator
• JOB CLASSIFICATION: Full-time, non-exempt
• LOCATION OF POSITION: Aurora Office
• THIS POSITION REPORTS TO: Quality Assurance Manager
• SUMMARY STATEMENT:
  • The Quality Assurance Coordinator assures compliance with government and industry standards.
  • The Quality Assurance Coordinator monitors SOP/document forms, change control process, champions a continuous quality improvement process and may be the Eye Bank’s OSHA representative.

ASSIGNED RESPONSIBILITIES AND DUTIES:

• Receiving and investigating departures, deviations and corrective actions
• Follow-up and tracking corrective action effectiveness
• As needed assist with SOP/document change control process
• Assist with records retention control
• Monitor equipment verification, maintenance, and cleaning records
• Perform activities associated with inspections, audits, monitoring, and trending
• Review / audit records and procedures for completeness, accuracy, and compliance
• Activities associated with vendors and contracted service providers – agreements, off site audits
• Review donor records for completeness, accuracy and data collection after distribution
• Perform customer service tasks with current and potential surgeons
• Assist with or conduct new surgeon orientation
• Receive, investigate and evaluate information to include complaints and donor new information
• Assist in managing adverse reactions/events and complaint trends
• Follow-up and data entry of pending recipient information for transplanted tissues, including Recipient Information Forms and Recipient Post-operative Follow-up Forms
• Provide feedback and training to technical staff related to chart completeness and accuracy
• Provide new employee safety training
• Assess organizational training needs as part of a team; design, coordinate and implement training programs
• Assist in compiling, disseminating, and examining statistical data as directed
• Complete Department of Health Serology Reporting.
• Perform other duties as necessary and as assigned by management

QUALIFICATION REQUIREMENTS:

• EDUCATION:
  • A Bachelor’s degree in a science related field is required.
  • Appropriate regulated industry experience or certification may be substituted for education.
  • Thorough knowledge of ocular anatomy and physiology as well as medical and medical terminology knowledge is needed to understand aspects of eye banking.
• EXPERIENCE:
  • The Quality Assurance Coordinator should have at least 2 years experience working in a regulated industry.
  • Knowledge and experience with FDA regulations and quality systems (cGTP or cGMP) is a must.
  • An understanding of auditing practices and basic statistical analysis is needed.
  • Familiarity with EBAA or AATB medical standards is a plus.
  • The Coordinator should have experience working with quality systems / programs, preferably in eye or tissue banking, medical diagnostics, medical devices or other medical areas.
  • Consideration will be given to candidates with equivalent experience or knowledge from a cross-over profession or industry.
  • The Coordinator should be familiar with MS Office, donor databases and electronic quality databases.
  • The Coordinator is responsible for performing administrative aspects that may include interaction with or within the Technical, Quality, Public Relations and Accounting Departments.
  • The position requires excellent people skills, as well as effective written and verbal skills for both internal and external communication.
  • The Coordinator may be asked to develop and maintain business relationships with surgeons, surgery sites and their staff in an effort to open communication channels for reliable quality monitoring.
  • The specific training is provided by the managers of each department where applicable.

COMPENSATION:

• Salary Range is dependent upon experience.
• RMEB provides a full benefits package to include healthcare, dental, vision, 401k, holidays, paid time off and flexible scheduling.

Apply and More information

• Resumes must be accompanied by a cover letter explaining how the applicant meets the job requirements and desired skills.
• Please email cover letter and resumes to mailto:swolff@corneas.org with applicant name and the job title listing in the subject line.
• note: The deadline for application submission is April 29, 2014.
• No phone calls, please.

General Information:

• Name: DAVID SERTL, M.S., RAC, CQA
• Phone:: +1 303-438-8950
• E-Mail: dsertl08@cs.com
• Linkedin: http://www.linkedin.com/in/davesertl
• ASQ Boulder Section on-line Resume David Sertl.pdf (Update Apr 2014)

Quality Scientist

• A versatile scientist with a unique understanding of both analytical chemistry and regulatory affairs and their relationship to the quality of FDA-regulated products.
• Utilizing critical thinking, networking and organizational skills to solve problems and move projects forward to successful completion.
• Innovating to optimize processes and drive improvements in the quality of regulated products.
• Contributing to inter-departmental teams resulting in the successful development and commercialization of new products generating sales of >$200M/year in an FDA-regulated industry.
• Skills Include: Quality & Investigations; Root Cause, OOS, CAPA; Critical Thinking; Regulatory Compliance; cGMP Requirements; Technical Review;

General Information:

• Company: Instrument Rental Labs
• Job Title: Calibration Technician
• Location: Broomfield, Colorado
• Duties: Electronic test and measurement equipment calibration.
• Salary: Competitive and commensurate with skill and experience.

Knowledge and capabilities:

• Current “CCT” (ASQ-Certified Calibration Technician) certificate.
• 5 + years of Calibration lab experience
• Operational knowledge of Fluke “Metcal” automated calibration software and interfacing procedures.
• DC, Low Frequency, Microwave, Impedance and general electrical and electronic equipment knowledge training and experience.
• Documentation experience with accredited calibration including ability to compute and construct uncertainty evaluations.

Note: no call please

to Apply

Send your resume with salary requirements with subject “Job: Calibration Technician” to BillH@testequip.com

General Information:

• Company FreeWave Technologies
• Job Title: Quality Engineer
• Job Tracking ID: 512437-431375
• Job Type: Full-Time/Regular
• Location: Boulder, CO
• Job Level: Mid Career (2+ years)
• Years of Experience: 5 – 7 Years
• Level of Education: BA/BS
• Starting Date : ASAP
• Position Overview:
  • The Quality Engineer will be reporting to the Quality Manager and help drive key quality initiatives throughout the company.
  • The main focus will the monitoring and closure of Quality issues internally and externally, and maintaining ISO certification in addition to improving processes by monitoring key metrics.
  • Work will be performed at the FreeWave Technologies location in Boulder, Colorado unless otherwise specified by functional Management.

Principal Job Functions:

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
• The requirements listed below are representative of the knowledge, skill, and/or ability required.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Work cross-functionally to ensure all ISO procedures are followed and Training Guides are utilized to standardize on and improve processes.
• Initiate and manage Non Conformance Reports (NCRs) from initial problem recognition to closure based on Field / Customer, Supplier, Manufacturing / Production, and Process issues.
• Perform internal audits to ISO procedures on a regular basis to ensure compliance to the QMS procedures for all functions at FreeWave.
• Document and maintain records in ISO Database.
• Conduct customer surveys to gauge FreeWave’s performance in the eyes of customers and satisfy one of the major Quality Objectives.
• Update and revise ISO procedures and maintain in database, to improve upon processes, where deemed necessary, as a continual improvement.
• Perform assessments and audits of major component suppliers, such as suppliers of electronic modules used on FreeWave products.
• Concentrate on supplier performance and drive issues with major components to resolution.
• Prepare and support Surveillance Audits that are conducted by ISO auditors yearly.
• Provide refresh ISO training to employees in preparation for the re-certification audit and support preparation for the re-certification audit.
• Manage supplier certification surveys and approval of new suppliers and updates to existing suppliers, keeping a current list and up to date certification in the ISO database.
• Manage corrective and preventive actions to ensure Non-Conformances are addressed and closed.
• This task will be ongoing as Quality issues are surfaced and need to be resolved throughout the company.
• Review quality metrics and data and use statistical techniques to show trending issues for product and process improvement.
• Utilize 8D reporting method to drive corrective and preventive actions.
• Maintain Employee List in ISO database and keep current with HR training and/or certification records.
• Work with HR to ensure all employees’ training is completed, verified and up to date and records in the ISO database are up to date.
• Work with Manufacturing and Engineering to implement and update Assembly Instructions on all products.
• Other duties as assigned
• Must be a US Person in accordance with United States immigration laws to be considered for this position.

Knowledge, Skills and Abilities:

• Four to seven year experience in developing and maintaining a Quality Management System (QMS) and supporting certification to ISO 9001/AS9100.
• Excellent written and oral communication skills are required.
• Excellent organizational skills and attention to detail are required.
• Demonstrated analytical expertise including ability to plan, resolve problems effectively, and establish priorities.
• Working knowledge of Quality Management Systems (QMS) is required.
• Internal auditing skills in ISO 9001 or others is highly desired.
• Knowledge in Printed Circuit Board and/or electronics is preferred.
• Must be a US Person in accordance with United States immigration laws to be considered for this position.
• Quality minded individual with proven records of promoting Quality as a major driver for customer satisfaction and retention.
• Certified Quality Auditor is highly desired.
• Certified Quality Engineer is a plus.
• Six sigma certification is preferred.
• Demonstrated ability to work cross-functionally to drive root-cause and corrective action where needed.
• Four to seven year experience leading efforts to address quality issues in Failure Review Board (FRB)/Material Review board (MRB) forum.
• In depth knowledge with performing and reviewing Process Failure Modes and Effects Analysis (PFMEA) and ability to apply its principles and results to process improvement.
• Applied experience in Statistical Process Control (SPC), Corrective and Preventive Action (CAPA), and Lean Manufacturing is highly desired.
• To be successful in this position, the candidate must have a commitment to quality in everything they do.
• This means continuous improvement of activities and processes.
• In order to do so, the candidate must show an ability to drive to root cause and resolve issues related to that cause.

Education and Experience:

• Bachelor Degree in a technical or engineering field, or 6-10 year equivalent combination of education and experience, is required.
• Experience working in an electronic Manufacturing environment is highly desired.

Physical Demands /Work Environment:

• Work cross-functionally to drive continual improvement in product and processes.
• Able to work in a noisy Manufacturing environment on an as needed basis.

Apply and More information

http://freewave.atsondemand.com/index.cfm?fuseaction=512437.viewjobdetail&CID=512437&JID=431375

General Information:

• Job Title: Director, Software Quality Engineering
• Location: Westminster
• Status: Direct Hire
• Start Date: 3/2014
• Pay Rate: $90 – 120k
• Overview
  • Expert level experience working with complex software systems in a Unix/Linux environment
  • Experience with LAMP stack, automated testing frameworks, testing tools
  • Seeking a highly talented Director of Software Quality Engineering to oversee the final integration and deployment of our code to production.
  • Quality Engineering team has end-to-end responsibility for the video platform
  • this position will be responsible for ensuring that the product quality engineers have the tools, services and environments they need to verify software and application.
  • In addition, this candidate will plan, develop and execute the overall quality engineering strategy.
  • This position is located in Westminster, CO and you must be authorized to work in the US to be considered.
  • You will be working in a fast-paced but casual environment with highly talented peers.
• The major areas of focus for this team include:
  • Building of testing tools to support our platform
  • Assistance with Continuous deployment tools and systems
  • Pushing development teams to meet a standard of quality before gaining access to production
• In this role, you will also require liaising with Developers, System Administrators and Product Owners to flesh out new requirements along with providing meaningful inputs to improve the overall software quality of our products.
• You will be working with a small team to deliver software in accordance with the timelines with highest possible quality.

Responsibilities:

• Provide feedback on the process to ensure continual improvement of the process
• Create automated acceptance tests for stories as required
• Create necessary automated testing frameworks, tools and services as required
• Communicate effectively in daily standup meetings, weekly planning meetings, and in cross departmental stakeholder meetings
• Be passionate about the software quality engineering
• Share experience and knowledge with colleagues, enabling others to learn and grow
• Have an inquisitive and quality-centric nature, and be willing to stand up and ask questions as required
• Be approachable and willing to collaborate with others where necessary
• Embrace change and responsibility

Required:

• Bachelors degree or higher in Computer Science or related discipline
• 3 to 5 years of practical experience as a Software Quality Engineer on software development teams
• Expert level experience working with complex software systems in a Unix/Linux environment
• Experience with LAMP stack, automated testing frameworks, testing tools
• Good understanding of agile software development
• Solid QA/Testing experience in highly available systems
• Proficient in working with databases such as MySQL and ability to write basic to complex SQL queries
• Understanding of Git, SVN, or other modern source control system
• Proponent of TDD and continuous integration
• Experience with SaaS and software at scale

Apply and more information

• Send Resume and Cover Letter to Jeff Himebaugh email: jhimebaugh@snitechnology.com
• with subject “Director Software Quality Engineering, Westminster, CO”

General Information:

• Company: Alliant National Title Insurance Company
• Title: Continuous Improvement Manager
• Location: Longmont, CO
• Summary:
  • The experienced and effective leader we seek will oversee and administer Quality Assurance for our Quality/Compliance Department.
  • Leading the continuous improvement and process development of Quality Assurance systems and processes;
  • Teaching/coaching Alliant National staff in applying quality and productivity improvement tools and methods to improve internal processes and service delivery to our agents;
  • Conducting internal process auditing;
  • Managing our “corrective action” process to assure timely and complete solutions that prevent the recurrence of issues.
  • Corrective action process encompasses internal processes as well as our agent Quality Review process.
  • You must successfully champion change at many levels working with internal staff while maintaining positive, professional and productive business relationships.

Responsibilities:

• Manage the Corrective Action Process; skilled at working cross functionally to complete Corrective Actions
• Employ project management techniques to ensure greater efficiency and timely completion of projects
• Lead and train team on process mapping, writing procedures, setting standards, measuring and analyzing data
• Review and analyze data for trends in the Corrective Actions and Claims
• Provide monthly updates to Senior Management
• Schedule and prioritize internal process audits
• Participate on the Agent Review team
• Review and analyze data resulting from internal process audits

Qualifications:

• Bachelor’s degree or equivalent work experience
• 5 years experience in process improvement
• Relevant continuing education and certifications in quality management/six-sigma tools
• Working knowledge of common database programs (Access / SQL)
• Six Sigma Green Belt Certification required; Lean Six Sigma experience in service industries helpful
• Fluent and proficient in software needed for quality and productivity improvement and Microsoft Office
• Demonstrated analytical ability; must be able to ’crunch data’ and draw conclusions accordingly
• Excellent verbal and written communication skills
• Ability to manage timelines and balance multiple deadlines
• Ability to manage to corrective actions
• Fluency in common tools used in quality management
• Excellent educator, trainer or coach with the ability to help others learn new skills that lower risks and improve efficiencies in operations
• Ability to motivate others to make improvements
• Must be a solid leader
• Excellent organizational and management skills
• Strong focus on customer service
• Ability to build positive and effective relationships with internal staff and agents
• Proven ability to balance the quality system objectives with the needs of the affected parties, including:
  • Insight and patience in providing enough time to make improvements versus requiring timely completion based on the risk at hand
  • Ability to hold people accountable in a positive and encouraging way
• Knowledge of Title Insurance Operations helpful
• Knowledge of SSAE 16 Type II audits helpful

Benefits:

• In exchange for your hard work and dedication, we offer a competitive salary, depending on experience, a positive working environment and an excellent benefits package including:
  • Health benefits
  • 401K retirement plan
  • Flexible spending account
  • Life insurance
  • Short and long term disability
  • Paid vacation and holidays

To Apply:

• To respond to this opportunity, please go to: Continuous Improvement Manager job

General Information:

• Company: FreeWave Technologies
• Title: Temporary Quality Engineer
• Position Overview (This is a Temporary Position for Q1 and Q2 2014):
  • The Quality Engineer will be reporting to the Quality Manager and help drive key quality initiatives throughout the company.
  • The main focus will the monitoring and closure of Quality issues internally and externally, and maintaining ISO certification in addition to improving processes by monitoring key metrics.
  • Work will be performed at the FreeWave Technologies location in Boulder, Colorado unless otherwise specified by functional Management.
  • To be successful in this position, the candidate must have a commitment to quality in everything they do.
  • This means continuous improvement of activities and processes.
  • In order to do so, the candidate must show an ability to drive to root cause and resolve issues related to that cause.

Principal Job Functions:

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
• The requirements listed below are representative of the knowledge, skill, and/or ability required.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Work cross-functionally to ensure all ISO procedures are followed and Training Guides are utilized to standardize on and improve processes.
  • Initiate and manage Non Conformance Reports (NCRs) from initial problem recognition to closure based on Field / Customer, Supplier, Manufacturing / Production, and Process issues.
  • Perform internal audits to ISO procedures on a regular basis to ensure compliance to the QMS procedures for all functions at FreeWave.
  • Document and maintain records in ISO Database.
  • Conduct customer surveys to gauge FreeWave’s performance in the eyes of customers and satisfy one of the major Quality Objectives.
  • Update and revise ISO procedures and maintain in database, to improve upon processes, where deemed necessary, as a continual improvement.
  • Perform assessments and audits of major component suppliers, such as suppliers of electronic modules used on FreeWave products.
  • Concentrate on supplier performance and drive issues with major components to resolution.
  • Prepare and support Surveillance Audits that are conducted by ISO auditors yearly.
  • Provide refresh ISO training to employees in preparation for the re-certification audit and support preparation for the re-certification audit.
  • Manage supplier certification surveys and approval of new suppliers and updates to existing suppliers, keeping a current list and up to date certification in the ISO database.
  • Manage corrective and preventive actions to ensure Non-Conformances are addressed and closed. This task will be ongoing as Quality issues are surfaced and need to be resolved throughout the company.
  • Maintain Employee List in ISO database and keep current with HR training and/or certification records.
  • Work with HR to ensure all employees’ training is completed, verified and up to date and records in the ISO database are up to date.
  • Work with Manufacturing and Engineering to implement and update Assembly Instructions on all products.
  • Other duties as assigned
  • Must be a US Person in accordance with United States immigration laws to be considered for this position.

Required Experience:

• Knowledge, Skills and Abilities:
  • Excellent written and oral communication skills are required.
  • Excellent organizational skills and attention to detail are required.
  • Demonstrated analytical expertise including ability to plan, resolve problems effectively, and establish priorities.
  • Working knowledge of Quality Management Systems (QMS) is required.
  • Internal auditing skills in ISO 9001 or others is preferred.
  • Knowledge in Printed Circuit Board and/or electronics is highly desired.
  • Must be a US Person in accordance with United States immigration laws to be considered for this position.
  • Quality minded individual with proven records of promoting Quality as a major driver for customer satisfaction and retention.
  • To be successful in this position, the candidate must have a commitment to quality in everything they do. This means continuous improvement of activities and processes. In order to do so, the candidate must show an ability to drive to root cause and resolve issues related to that cause.

Education and Experience:

• Bachelor Degree in a technical or engineering field, or 3-5 year equivalent combination of education and experience, is required. Associate Degree may be considered based on combination of education and experience.
• Experience working in an electronic Manufacturing environment is highly desired.

Physical Demands /Work Environment:

• Work cross-functionally to drive continual improvement in product and processes.
• Able to work in a noisy Manufacturing environment on an as needed basis.

Apply and More information

http://freewave.atsondemand.com/index.cfm?fuseaction=512437.viewjobdetail&CID=512437&JID=429095