Job Opportunities

Company: Platinum Registration

Location: 720 South Colorado Blvd., Penthouse North, Denver, CO

Title: ISO 9001 and 9100 Auditors

Looking for contract 9001 auditor (9001 and 9100 would be great) who speaks Spanish.

• Supplemental your income. Over time, audit days can be built up to a desired capacity.
• Flexible for travel and having a broad base of industry experience increases opportunities for audit assignment.
• Personal skills and loyalty are paramount.
• We expect all auditors to work with courtesy and integrity.
• Auditors must operate as part of our team and fit in with established processes and methods.

For more information and to apply contact:

Melody Sands, Staff Auditor, Platinum Registration,

• 720 South Colorado Blvd., Penthouse North, Denver, CO 80246
•  Office: 303.639.9001
• Direct: 720.280.7632
• email: melody@platinumregistration.com
• web site: www.platinumregistration.com

Title: Supplier Quality Engineer in Fort Collins CO

Type: Full time, Direct Hire

Placement Company: Aerotek Engineering

Location: Fort Collins, CO

Job Description:

The Supplier Quality Engineer (SQE) position has a strong understanding of Quality methods and systems.

The SQE is responsible for implementation and execution of methods and programs to ensure that suppliers have systems that meet specifications and standards.

This position interfaces with the sourcing team and communicates direction to suppliers on issues such as;

• quality performance improvement,
• part approval process,
• sampling plans,
• inspection methods,
• measurement system analysis,
• statistical process control contract reviews,
• problem investigations,
• evaluation of quality systems,
• product transition activity.

This is a Direct (Full-Time) role

Qualifications:

• 4 year degree in technical field of 5-7 years of quality, manufacturing or process control experience
• May have ASQ Certification
• 4+ years quality engineering experience
• Must have experience managing supplier relationships and validating their quality metrics, standards and processes
• Automotive or Aerospace experience preferred
• Experience with APQP and DFSS

For more information and to apply Please contact Tionne Webb

• Direct Line: 720-773-3932
• Email: twebb@aerotek.com

Title: Quality Engineer and Technician in Louisville CO

Type: Full time, Direct Hire

Company: Cannabis Manufacturer

Location: Louisville, CO

Information

A Cannabis manufacturer in Louisville, CO is looking for full time direct hire

• One Certified Quality Engineer (ASQ CQE)
• Several Certified Quality Technicians (ASQ CQT)

With preferred FDA based cGMP quality system (21 CFR 111 and 117) experience

For more information and to apply please contact:

• Cary Black, Orion GMP International
• email: cary@oriongmp.com
• Consultant in Cannabis Standards and Good Manufacturing Practices

Company: Hirsh Precision Products,

Location: 6420 Odell Pl, Boulder, CO

About: Hirsh Precision Products

• Designs, manufactures, and ensures the quality of precision-machined parts and assemblies.
• Our cutting edge equipment, technology, and processes attract the attention of multiple industries.
• We specialize in production machine work with precise and exacting cosmetic and dimensional quality requirements.
• We have been providing these services since 1979, and can ensure industry leading experience and capabilities.
• Our mission is to provide the highest quality products and manufacturing services, delivered on time.
• We are committed to continuous improvement and to conducting business with integrity.

Job: Director of Quality

• Provides strategic, operational and thought leadership to support the companies mission and core values.
• Works collaboratively with the Leadership team to develop and implement innovative manufacturing solutions and to ensure compliance to the Quality Management System.
• Detail information PDF flyer  (160 KB)

Job: Quality Engineer

• Understands the principles of product and service quality evaluation and control.
• The primary purpose is to provide Quality Engineering support for Operations to ensure the highest level of quality product and service is produced in accordance with the Quality Management System.
• Detail information PDF flyer (540 KB)

Job: Quality Technical Lead

• Serves as the day-to-day leader of the Quality team.
• Quality team is responsible for performing inspections to assure the highest level of quality products and services are produced in accordance with the Quality Management System.
• Detail information PDF Flyer (170 KB)

Job: Quality Technician

• Responsible for the daily inspection tasks required to support manufacturing production.
• Responsible for performing inspections to assure the highest level of quality products and services are produced in accordance with the Quality Management System.
• Detail information PDF Flyer

To Apply

• Visit Hirsh Precision Products’ Career Web Site 
• Or contact Peter Doyle, Chief Operating Officer, Hirsh Precision Products
  Email: peter.doyle@hppi.com

Company: Roccor, LLC

Location: 2602 Clover Basin Drive, Suite D, Longmont, CO

Position: QA Specialist

Job Type: Permanent

Job Description

Roccor is a fast-growing, vibrant, high technology aerospace supplier in the aerospace, thermal management, and combat care industries.

Roccor’s novel designs address cost and performance limitations to revolutionize spaceflight and military operations.

Roccor has contracts with NASA, the U.S. military, and commercial space companies all around the world and have already delivered five spaceflight deployable systems for use on U.S. government orbital programs.

By the summer of 2018, Roccor will have flown 25 spaceflight deployable systems on a cubesat and ESPA class satellites.

QA Specialist Specifics

Support Roccor’s cutting-edge, high technology programs across all departments.

Perform a blend of technical and administrative tasks, including document management, process improvement, maintaining material traceability, and inspection of incoming, in process, and completed materials and assemblies.

Responsibilities will include:

• Examining material or product and comparing with drawings and/or compliance documents
• Reviewing and approving documents and drawings
• Serving as a point-of-contact for nonconforming materials and products
• Quarantining defective parts and assisting with disposition
• Assisting others with completing corrective actions
• Managing inventory of aerospace parts and materials
• Retaining Quality Assurance records

What you bring to the table:

• Experience in Aerospace or Bio Med fields
• A strong backbone under your superhero cape
• Great organizational skills
• Self-starter who anticipates problems, spots opportunities, assumes responsibility
• Proficient in MS Office

Roccor culture encourages our team to come up with innovative solutions to problems.

Roccor people are highly collaborative and focused on building a world-class team.

Roccor’s core values are:

• Ownership
• Passion
• Respect
• Trust
• Agility
• Teamwork and Collaboration

More Information and to Apply visit QA Specialist job web page

Company: Hunter Douglas, Inc 

Location: 1 Duette Way, Broomfield, CO

Position: Product Safety Compliance Analyst

Job Type: Full Time

Job Description

Hunter Douglas is the world’s leading manufacturer of window coverings as well as a major manufacturer of architectural products

Essential Functions:

• Manages systems and documentation programs to ensure Hunter Douglas North America (HDNA) fabrication sites comply with industry safety standards for the US and Canada. Supports administration of HDNA involvement in the WCMA Best For Kids program.
• Oversees and participates in a multi-faceted audit program that includes conducting annual on-site audits for an estimated 20 or more locations.
• Manages a weekly review of product audits submitted through the iPad Safety PEP app program.
• Conducts and manages a “Secret Buy” Program to audit product from selected HDNA sites and competitors.
• Collaborate with the Window Fashions test lab site on audit findings, recommendations and solutions.
• Manages a “Virtual Team” of safety contacts for each HDNA site and group.
• Facilitates a quarterly webex session for all HDNA sites on current items related to standard compliance.
• Provides presentation materials for each October as National Window Covering Safety Month campaign.
• Responsible for designing and tracking the master spreadsheet of compliance information for all HDNA company products.
• Works closely with manufacturing and fabrication to encourage design improvements that enhance child safety features.
• Serves as an auditor of products, processes, corporate-owned suppliers, external suppliers and quality systems, on an as needed basis.
• Manages the Compliance Guideline program, including HDNA QS-001 document with visual interpretations of the US and Canadian Safety Standards.
• Develops and conducts training for all locations as Safety Standard updates and changes are implemented.
• Adminsters HDNA participation in the WCMA “Best for Kids” program.
• Supports the Lead Testing program as described in the HDNA 100 Lead Content Standard.
• Works with the Hunter Douglas Broomfield Test Lab and its HDXRF equipment.
• Prepares and submits verbal and written presentations to Hunter Douglas management on a regular basis.
• May serve as a “field investigator” for product safety incidents.
• Will report through the Corporate Quality Organization to the Director of the Quality System Review.

Qualifications:

• An employee in this position, upon appointment, should have the equivalent of the following:
• Basic knowledge of Fabrication processes and systems.
• Basic knowledge of auditing techniques
• Strong written and verbal communication skills
• Ability to manage projects, schedule and work to deadlines and work without direct supervison.
• Ability to analyze cause and effect relationships in a problem and use problem analysis to develop resolution alternatives.
• Ability to develop new programs and/or change programs to meet changing trends and needs.
• Willing and able to Travel to HDNA sites to conduct audits.

Acceptable Training and Experience includes

• Bachelor’s Degree in Business Management, Operations, or Engineering is required or equivalent years of experience in lieu of degree.
• Five to Seven years business experience in Window Covering Industry preferred.
• Experience in Auditing such as ISO and/or ESAFE is useful; Certification in ASQ as a Quality Manager, Quality Auditor or Quality Engineer is desirable.

Apply To: Liz Steves, Corporate Recruiter Liz.Steves@HunterDouglas.Com
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Title: Quality Assurance Sr Manager Assoc Director at St-Renatus in Fort Collins CO

Company: St. Renatus

Location: 1000 Centre Ave, Fort Collins, CO

Job Type: Full Time

Job Description

• This position will provide Quality leadership and oversight of contract manufacturing organizations (CMO) plant operations.
• Ensuring appropriate application and execution of cGMP compliance requirements for combination product.
• It will also review and revise current quality policies in place and further develop and execute St. Renatus’ Quality Management Systems in a manner that ensures successful deliver of cGMP Quality Assurance.
• This position performs related tasks that fall under the broad category of Quality Assurance functions.
• Such tasks will include conducting investigations, determining and/or completing corrective and preventive actions (CAPAs),
• Reviewing Master Batch Records and Master Packaging Records,
• Reviewing Validation Protocols and Qualifications, conducting audits,
• Evaluating change controls for impact on other cGMP systems.
• In addition, this position will manage all aspects of the document control and training program and be responsible for authoring standard operating procedures.

Job Responsibilities

• Maintain the cGMP Quality Management System and standards for all aspects of supply chain.
• Provide virtual cGMP Quality oversight for all manufacturing, packaging, storage, and  distribution activities to ensure compliance.
• Perform final batch release activities for products manufactured by third parties.
• Review all third parties contracted to perform any functions in support of the cGMP manufacture of clinical supplies and commercial product.
• Identify cGMP compliance gaps or risks.
• Identify and monitor vendor performance metrics and improvement targets.
• Prepare, review, and monitor vendor adherence to Quality Agreements.
• Plan and conduct cGMP audits of manufacturing activities to assess compliance with pertinent regulations, as well as, with company SOPs.
• Review and approve product specifications, stability protocols/data, manufacturing deviations, Corrective Action Preventative Actions (CAPAs), SOPs, Change Control procedures.
• Establish the processes and communications to enable effective delivery on cGMP Quality commitments to build a culture of quality and continuous improvement.
• Ensure prompt communication of cGMP compliance risks to senior management.
• Oversight of pharmacovigilance monitoring program.
• Maintain Quality documentation files.
• Coordinate CMC compliance with Regulatory Affairs, including technical writing and review.
• Execute improvement activities, prepare periodic quality reports, and communicate progress to stakeholders.
• Oversee and facilitate Product Recall System.
• Ensure the periodic assessment of compliance standards and communication of compliance liabilities to senior management. Communicates this assessment on a regular basis.
• Develop and deliver cGMP compliance training and participate with training and development of staff.
• Participate as member of the management team in planning to achieve site goals and objectives; communicates and helps resolve issues or problems that have interdepartmental impacts and in planning to enhance and expand the opportunities
• Determine necessary headcount within Quality area to ensure delivery against goals.
• Management responsibility for non-exempt, exempt and/or supervisory level personnel as the company grows.
• Travel for this position is required (Approx. 10-15% Domestic)

Education / Experience

• BS or BA degree preferred, with emphasis in biosciences, biomedical, or medicine.
• Strong scientific background with at least 8 years of relevant experience in Quality Assurance in the manufacturing environment within the pharmaceutical industry.
• Thorough knowledge of quality systems, compliance regulations, scientific terminology, quality assurance procedures and policies, the use of computer and software developmental methodologies and quality auditing/evaluation techniques.
• Must have experience in the use of controlled documents and related quality systems.
• Previous experience with pharmaceutical production processes and Quality Control analytical methodologies.
• Knowledge of the principles of Quality Management and Continuous Improvement.
• Proven track record of successfully managing Quality Management, Quality Assurance, and Quality Control throughout the lifecycle of a pharmaceutical product.
• Experience in pharmaceutical equipment operation, design and control.
• Experience in leadership roles
• Facility Licensing, Regulatory audits and inspections for combination products.
• Competencies
• An investigational nature is essential in evaluating Quality problems.
• Maintains thorough and ongoing knowledge of cGMP methods, compliance and regulatory standards.
• Problem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality.
• Outstanding verbal, written and interpersonal communication skills. Effective written and oral communication skills is required.
• Demonstrated attention to detail with solid coordinating, task planning and time management skills.
• Must be multi-task oriented and organized to work within numerous systems and programs.
• Demonstrated skills in strategic thinking, problem solving, advising, risk assessment, risk mitigation, decision making, and implemention.
• Strong computer skills including but not limited to Microsoft Office products such as Outlook, Word, Excel, and PowerPoint, and ERP software related to manufacturing and project management.
• Ability to work independently and in a team environment, with strong leadership, negotiation and influencing ability.
• Demonstrated ability to build confidence among contract manufacturers, vendors, peers, customers, and others, quickly.
• A positive, winning attitude.

To apply, please send resumes/cover letters to: Recruiting@st-renatus.com

Company: Platinum Registration 

Location: 2401 South Downing Street, Denver, CO 80210

Title: Auditors

Looking for auditors for Colorado audits (some travel audits but not required)

• Experienced in Basic Metals and Fabricated Metal products, Electrical/Optical, Other services, Rubber and Plastic, and Machinery and Equipment industries preferred
• Auditing to ISO 9001:2008 and 9001:2015 required.
• ISO 9001:2015 Lead Auditor course completion required.

For more information and to apply contact:

Melody Sands, Staff Auditor, Platinum Registration,

• 2401 South Downing Street, Denver, CO 80210
• Office: 303.639.9001
• Direct: 720.280.7632
• email: melody@platinumregistration.com
• web site: www.platinumregistration.com

Company: Tenere

• Title: Quality Assurance Inspector
• Location: 1100 West 120th Avenue, Suite 100, Westminster, CO
• Category: QA/Quality Control
• Type: Full Time
• Tenere Inc. is a Custom Integrator providing metal fabrication, plastic molding, assembly & engineering services to the High Tech Industry.

Summary

• Inspect and record results on vendor, customer or sub-contractor supplied product, in-process parts and final product using appropriate measuring equipment, cosmetic specifications and documentation and forms.

Essential Functions

• Decisions include the choice of inspection tools, inspection methods, interpretation of specifications, additional frequency of inspection beyond MIP, PIP, FIP requirements and initial acceptance or rejection.
• Perform part and material inspections, analysis and documentation which meets the requirements of internal and external customers and complies with accepted practices.

Knowledge, Skills and Abilities

• High school diploma or equivalent
• One year of experience as Quality Inspector

For information and to apply see Tenere’s Quality Assurance Inspector job web page

Company: FreeWave

Summary: 

• Job Title: Sr. Regulatory Compliance Engineer
• Job Location: 5395 Pearl Parkway, Boulder, CO
• Job Tracking ID: 512437-548059
• Level of Education: BA/BS
• Job Type: Full-Time/Regular
• Date Updated: March 20, 2017
• Years of Experience: 7 – 10 Years
• Starting Date: ASAP

Recruiter: Matthew Ashenden

• Phone: +1 972-473-1104
• email: matthew.ashenden@networkerstechnology.com

Job Description:

• Manage domestic and international qualification of wireless products through certification & registration processes such as FCC, UL, ETSI and other product level qualification processes

Functions and Responsibilities:

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.

• Responsible for monitoring, interpreting and implementing worldwide laws and directives with regards to regulatory compliance of wireless access products – Primarily Radio Standards, EMC, Environmental and Safety.
• Ensure proper documentation and/or certificates are obtained within the appropriate timeframes in order to ship products as appropriate (Certificates of Origin, End User Certificates, State and Commerce Department Licenses, etc.).
• Provide technical assistance and guidance on testing required and done in support of regulatory compliance.
• Produce and maintain required test data (internal and external) to show conformance to legal and regulatory requirements.
• Experience with ITAR and Commerce related compliance considered a plus.
• Must be a US Person in accordance with United States immigration laws to be considered for this position.

Experience and Skills:

VERY IMPORTANT – Have homologated networking products in the following countries: United States, Canada, Mexico, Brazil, Saudi Arabia, UAE, Egypt, China, S. Korea, Philippines, India, Thailand, Singapore, Australia, UK, Germany, Denmark, Belgium, Russia, France, Austria

• Experience with ESD, EMC and EMI testing (emissions and immunity) preferably on the design level. Ability to review designs and offer suggestions for improvements.
• Familiarity with requirements for HAZLOC and ATEX.
• Experience with RF performance measurement and radio attributes.
• Experience with generating, reviewing and executing regulatory compliance test plans preferred.
• Demonstrated understanding of worldwide wireless regulatory agencies and their processes, procedures, and requirements is highly desired
• Demonstrated technical knowledge of wireless transceiver technology is highly desired
• Experience in legislative review, analysis and reporting is highly desired
• Extensive knowledge of regulatory compliance process involving regulatory bodies/standards such as UL, CSA, CB-Scheme, ETSI, CE and FCC.
• Familiarity with requirements for ITAR and Export Administration Regulations (EAR) desirable.

Education:

• BS in related technical discipline and 5-10 years of experience with research and implementation of regulatory compliance requirements, as well as test plan and execution experience or equivalent combination of education and experience.

About FreeWave:

• FreeWave Technologies is in one of the most exciting chapters of its 24-year history.
• FreeWave is currently a Machine-to-Machine (M2M) wireless communications leader and is rapidly expanding its product base to become an Industrial Internet of Things (IIoT) powerhouse.
• Today FreeWave has a solid wireless platform that currently serves thousands of industrial customers.
• In addition, FreeWave has just released the new ZumLink and WavePro platforms that enable greater versatility including programmable functionality at the edge of IIOT networks.
• FreeWave Technologies, Inc. engineers and manufactures certain products that are considered ITAR-controlled items under the International Traffic in Arms Regulations (ITAR).
• Consistent with ITAR, any position at FreeWave that involves work with the engineering or manufacturing functions of the Company may only be filled by a candidate who is (i) a citizen of the United States, or (ii) a person who has been accorded the privilege of residing permanently in the United States as an immigrant in accordance with the immigration laws.

EOE/M/F/V/D

• FreeWave is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or Veteran status.

For more information and to apply,  contact

Recruiter: Matthew Ashenden

• Phone: +1 972-473-1104
• email: matthew.ashenden@networkerstechnology.com