Job Opportunities

General Information:

• Company: Aircell 
• Title: Manufacturing Quality Engineer
  • The Quality Engineer, Production Operations, reports to the Senior Quality Manager and works as part of the Quality Assurance team serving as the front line technical support of the Aircell Production Operations area.
  • In this hands-on position, the ideal candidate ensures that the parts that are produced meet all design and functional requirements, as well as customer expectations.
  • In this position, the ability to quickly and effectively take action when non-conformances are found is critical.

Responsibilities

• Responsible for quality assurance of new and existing programs at all manufacturing stages to ensure the quality of production meets engineering drawings, specifications, and customer requirements.
• Support the goal of zero defects with focus on minimizing the current out of box failure rate in the field.
• Lead the development of Process Failure Modes and Effects Analysis (PFMEA) for new and existing products.
• Provide engineering support to Production Operations by serving in the lead role as Tier 1 technical support performing effective top level fault analysis on all production rejects.
• Take action, including accurate root cause analysis, dispositioning the rejected material as appropriate.
• Will work closely with Production Operations Supervisor, Product Quality Engineer, and Supplier Quality Engineer.
• Develop methods to measure and continuously monitor production yields identifying root cause of low yields and defining and implementing corrective actions.
• Define and report on Production Operations process metrics.
• Determine when process capability and stability studies should be performed on existing processes.
• Review and analyze results, recommending, and owning changes based on findings.
• Perform follow up to verify effectiveness.
• Owner for the Production Operations First Article Inspection (FAI) process.
• Responsibilities include identifying, scheduling, and performing first articles for all internally manufactured products, as well as documenting and resolving all issues that may be detected preventing the first article from being approved.
• Assist the Senior Quality Manager in the development and improvement of the AS9100 Quality Management System in the Production Operations area, which may include product and internal audits.
• Strong drive for continuous improvement through the application of lean principles and a 6-sigma methodology with a focus on removing waste and cost from the operation.
• Implement tools and techniques that mistake proof Production Operations and increase the quality of the process outputs
• Self-driven to achieve defined goals and metrics with proven ability to think independently to develop new and unique approaches to problem solving and continuous improvement.

Other experience, skills and talents

• Minimum of a bachelor’s degree in Electrical Engineering or related discipline with 5 to 7 years of experience in a manufacturing quality engineering position with 5S/Lean manufacturing and ERP/MRP systems.
• Certified Quality Engineer preferred.
• Basic electronics knowledge for printed circuit board assemblies (PCBAs) including interaction and function, as well as electromechanical systems with embedded software.
• Ability to interpret electronic schematics, including inputs, outputs, and operation.
• Proven complex analytical and problem solving skills, including knowledge of LabVIEW, coding, and automated test development, the ability to configure network devices, and the ability to debug test equipment.
• Proficient computer skills with office software applications and a proven ability to use data analysis tools.
• Strong attention to detail, task organizational, and communication skills, and the ability to identify opportunities to drive sustained ongoing improvements in yields and throughput.

Apply

• For more information and to apply see AirCell job posting http://hire.jobvite.com/CompanyJobs/Careers.aspx?c=qse9Vfwu&cs=95baVfw5&su=fnH9VfwS&page=Job%20Description&j=o4ZoYfw9

General Information:

• Company: Bard Medical Division-TTM
• Title: Software Quality Assuarance Engineer
• Job id: 2013-6861

Overview:

• Provide quality software engineering support in design and development of medical device products, specifically, patient temperature management products.
• Responsible for performing various software quality assurance activities whose main purpose is to facilitate continuous improvement for both products and processes and to support new product/process development activities.
• These activities include software life cycle management, design control & documentation, requirements engineering, test case engineering and coverage, configuration management, risk management, usability engineering, design verification and validation, process validation, failure analysis, corrective and preventive action, performing internal and supplier audits to verify compliance with ISO and FDA/QSR Regulations, supporting external audits, personnel training and hands-on software testing.

General Responsibilities:

• Develop, implement and maintain standards for software quality processes, systems and procedures to support the software life cycle
• Ensure that software project and process control documentation are compliant with established procedures
• Support Research and Development, Manufacturing, Production and IT in Software Quality Assurance
• Review product requirements for traceability, risk remediation and testability
• Review verification and validation deliverables for compliance with regulatory requirements
• Review software test harness / test cases for clarity and requirements coverage
• Preparation and analysis of periodic Quality Reports
• Perform internal and support external audits of products and processes
• Selection, qualification and monitoring of outside suppliers
• Preparation and review/approval of Engineering Changes and MRB Materials
• Collect, analyze and take action on performance measurement indices, statistical capability/ reliability analysis
• Enhance the Quality Management System in such areas as Design Review Process, Compliance to Standards, Change Management, Software BOM enhancements, and Device History File (HDF)
• Lead specific continuous improvements initiatives which will evolve into a more robust software quality assurance process. Track software problem reports and deviation up to closure
• Support the development , update, validation, and documentation of software utilized in the automated testing of printed circuit boards and finished medical devices
• Assist in maintaining, troubleshooting, and repairing software elements of automated test systems utilized in manufacturing and service
• Support IQ/OQ/PQ activities involving software based manufacturing and service equipment

Basic Qualifications

• Bachelor of Science Degree or equivalent experience
• 5 to 7 years experience testing medical device software as well as establishing and upholding software life cycle processes
• Demonstrate sense of good leadership style with the ability to act as change agent within organization
• Comfortable working in a software and hardware medium scale system level product environment with associated test equipment and cabling
• Strong organizational, time-management, verbal and written communication skills

Applying:

• For more information and to apply see job posting https://jobs-crbard.icims.com/jobs/6861/job

General Information:

Company: Colorado Dept of Transportation, Denver, CO

Hiring: Process Improvement Interns (Winter and Summer terms)

Part-time during the Winter term:

• Job Title: Intern: Part-time Process Improvement Assistant -Winter
• Class Title: STUDENT TRAINEE I
• Type of Announcement: This position is open only to Colorado state residents.
• Application Closing Date/Time: Mon. 01/20/14 11:59 PM Mountain Time
• Primary Physical Work Address: 4201 E. Arkansas Ave. Denver, CO 80222
• Salary: $15.62 Hourly
• FLSA Status: Non-Exempt; position is eligible for overtime compensation.
• Job Type: Temporary (9 months or less)
  • This part-time position is expected to work the following number of hours per week:
  • This position is part-time to accommodate student schedules.
  • Final schedule will be determined upon hire.
• Location: Denver, Colorado
• to Apply and for more Information see http://agency.governmentjobs.com/colorado/default.cfm?action=viewJob&jobID=785837

Full-time this Summer:

• Job Title: Intern: Process Improvement Assistant – Summer Full-time
• Class Title: STUDENT TRAINEE I
• Type of Announcement: This position is open only to Colorado state residents.
• Application Closing Date/Time: Sat. 02/15/14 11:59 PM Mountain Time
• Primary Physical Work Address: 4201 E. Arkansas Ave., Denver, CO 80222
• Salary: $15.62 Hourly
• FLSA Status: Non-Exempt; position is eligible for overtime compensation.
• Job Type: Temporary (9 months or less)
  • This part-time position is expected to work the following number of hours per week:
  • This position is part-time to accommodate student schedules.
  • Final schedule will be determined upon hire.
• Location: Denver, Colorado
• to Apply and for more Information see http://agency.governmentjobs.com/colorado/default.cfm?action=viewJob&jobID=785945

General Information:

• Company: Surefire Medical, Westminster, CO
• Position: Quality Assurance Engineer
• Reports to: VP, Regulatory Affairs and Quality Assurance
• Surefire Medical, Inc., a Westminster, Colorado-based medical device company that develops and manufactures intravascular catheters for use in interventional radiology, is seeking a Quality Assurance Engineer. You must be an experienced quality professional, who is a self-starter and is comfortable in a fast-paced setting.

Responsibilities:

Effectively communicate within all levels of the organization around concepts of process controls/validation; failure investigation and root cause analysis, inspection/test methods, sampling/statistical techniques, corrective and preventive actions, and risk management.

• Process Validation/ Monitoring: Collaborate with Operations Team in process validation and monitoring activities, including IQ/ OQ/ PQ, Test Method Validation. Write product Quality Plans. Implement and monitor product and process quality using statistically based techniques.
• Risk Management: Lead product and process risk assessment activities: FMEA and Risk Management Reports.
• Supplier Quality: Lead supplier qualification activities including conducting supplier audits. Manage the Supplier Performance Program. Interface with suppliers to drive corrective actions.
• Non-Conforming Materials: Manage the non-conforming materials program, including investigation and disposition activities. Communicate quality issues to vendors.
• Customer Complaints: Manage the customer complaint handling process, including performing failure investigations and root cause analysis.
• CAPA: Perform quality data analysis and issue quality trend reports. Manage the CAPA program, including identification of quality issues/trends, perform or lead root cause analysis activities, identify and manage corrective/preventive actions, oversee CAPA implementation and assess effectiveness.
• General: Provide technical leadership and support to the Quality and Engineering teams (e.g. inspection/test activities, calibration, cleanroom certification and monitoring, sterilization validation.) Assist or lead quality system improvement projects. Perform other quality activities and projects as assigned.

Qualifications:

• BS in Engineering, Science, Biomedical or related field of study. CQE certification a plus.
• 5+ years of Quality Assurance Engineering in a medical device company. Experience in the manufacture of sterile disposable products a must. Experience with intravascular devices a plus.
• Knowledge and application of US and international standards for quality management (FDA 21 CFR 820, ISO 13485), risk management (ISO 14971), biocompatibility (ISO 10993-1), ethylene oxide sterilization (ISO 11135), sterile product packaging (ISO 11607), product microbial monitoring (ISO 11737) and cleanroom monitoring (ISO 14644).
• Knowledge and application of statistical techniques, SPC, DOE, and problem solving tools.
• Adept in use of computer software for the analysis of data, such as Microsoft Excel and Minitab.
• Must possess a strong sense of urgency, teamwork, keen attention to detail, ability to plan, organize and multi-task.
• Excellent communication skills (oral and written).

Apply information

Qualified candidates should forward their resumes with cover letter and salary requirements to info@surefiremedical.com with subject:Job Quality Assurance Engineer

General Information

• Company: Medtronic, Louisville, CO
• Hiring: Sr Software Quality Engr (STQRA)
• Requisition: 89350
• Category: Regulatory Affairs and QA
• Business: Surgical Technologies
• Job Type: Full Time – Regular

Position Description

• Works with minimal guidance to support the design, development, test, and market release of software used in both surgical navigation applications and other medical devices.
• Contribute to the processes and tools used to create and test software applications. Develop and assess the quality programs and systems of Medtronic Navigation to applicable standards.

Position Responsibilities

• Actively participate in product development cycle by reviewing software project documentation, participating in product risk assessments, and working closely with Product Development to develop appropriate verification and validation testing requirements.
• Work cross-functionally to implement improvements to the software life cycle, including the establishment of risk management as an integral part of the quality management system as an overall framework for the application of appropriate software engineering methods and techniques.
• Create and revise Standard Operating Procedures (SOPs) and other documentation to support the Quality System in regards to software and system design.
• Identify and implement software process metrics for the software product development life cycle. Develop, analyze and monitor metrics pertaining to software defects uncovered during development, testing and post-release.
• Recommend and lead corrective and preventive actions to improve software product quality. Ensure documentation and findings are completed on time and in a timely manner in accordance with FDA and European Regulatory agency standards and procedures.
• Provide solutions to a wide range of difficult challenges. Work independently to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives.
• Provide QA oversight to assigned suppliers. Disposition nonconforming product at the Material Review Board meetings. Interface as necessary with suppliers to ensure product specifications are met. Lead supplier audits and assessments.
• Promote continuous improvement through the use of such tools as Lean, Six Sigma and Kaizen.
• Follow all Quality System Practices as defined by Medtronic Navigation’s practices, policies and Standard Operating Procedures (SOPs) to ensure that FDA, ISO and European Medical Device quality standards and regulations are met where applicable.

Basic Qualifications

• EDUCATION REQUIRED
  • B.S./B.A. in Engineering or similar related field
• YEARS OF EXPERIENCE
  • 5+ years of previous experience in an engineering position with B.S./B.A.
  • 3+ years of previous experience in an engineering position with M.S./M.A.
  • 0+ years of previous experience in an engineering position with Ph.D.

Desired/Preferred Qualifications

• Working knowledge of FDA Quality System Regulations, Medical Device Directive, ISO 13485, ISO 14971, and ISO 62304 standards.
• Skilled in product risk assessment, requirements management and tracing, defect tracking, configuration management techniques, and how they are applied in the software development lifecycle.
• Some knowledge in one or more of the following areas: C/C++, Linux/Unix, Java, External Communication (RS-232, TCP/IP, wireless)
• Formal training in Lean and Six Sigma methods combined with project deployment experience at the green belt or greater level is highly desirable

For More information and to apply contact

see Medtronic career web link Search by Req ID 89350

General Information:

Company: NEON (National Ecological Observatory Network), Boulder, CO

• Hiring: Quality Inspector
• Summary:
  • This position reports to the Quality Manager.
  • The Quality Inspector examines products and materials for defects or deviations from NEON’s specifications.
  • The Quality Inspector will be trained to support the Quality and Reliability, Availability, Maintainability and functional Safety (RAMS) processes.
  • The primary responsibility regarding quality processes is assisting in quality inspections.
  • The Quality Inspector’s secondary responsibility is quality audits.
• Essential Duties and Responsibilities:
  • Performs visual inspection of printed circuit board assemblies (PCBA), sub-assemblies and systems or units to ensure all products meet the established specifications for reliability and workmanship.
  • Performs visual inspection of custom fabricated electronic cable assemblies to ensure all products meet the established specifications for reliability and workmanship.
  • Takes action on products that do not inspection specification standards (e.g., accept or reject finished items, remove products and materials that fail to meet specifications).
  • Utilizes gauges, templates, microscopes, and other manufacturing aids to ensure that all products meet the established specifications for reliability and workmanship.
  • Utilizes camera and if applicable microscope to capture defects and report on findings.
  • Ensures that all required process operations have been performed on the product that is being inspected.
  • Enters all quality data into the appropriate electronic or manual systems.
  • Notifies the appropriate personnel if unusual product defects are identified or if process yields “fall below acceptable” levels.
  • Provides timely feedback to manufacturing if non-conforming product is identified.
  • Accurately completes all administrative activities associated with quality inspection (e.g., record-keeping, documentation).
  • Performs process audits and assists manufacturing with the interpretation of the quality and workmanship standards.
  • Assists with the disposition of all non-conforming materials/product.
  • Analyzes quality data and initiates containment actions as appropriate.
  • Organizes material and completes writing assignments according to set standards regarding order, clarity, conciseness, style, and terminology.
  • Maintains records and files of work and revisions.
  • Analyzes data or information, identifying the underlying principles, reasons, or facts of information by breaking down information or data into separate parts.
  • Selects photographs, drawings, sketches, diagrams, and charts to illustrate material.
  • Travels (using own vehicle, reimbursed for mileage) to supplier site to on-site conduct source inspection.
  • Follows NEON and site specific environmental protection and safety requirements, policy and procedures.
• Required Education, Experience, Knowledge, Skills:
  • Associate’s degree or equivalent experience. Equivalent education and experience may be considered.
  • Three to five (3-5) years of related experience in manufacturing.
  • IPC-A-610 latest revision, Acceptability of Electronic Assemblies, Class 2.
  • IPC/WHMA-A-620 latest revision, Requirements and Acceptance for Cable and Wire Harness Assemblies, Class 2.
  • Knowledge of customer specifications for cosmetics and workmanship.
  • Knowledge and ability to read and interpret customer drawings.
  • Root cause / corrective action expertise.
  • Effective communication skills (written and verbal).
  • Ability to multitask.
  • Very effective written and verbal communication skills.
  • Ability to work effectively with diverse teams.
  • Self-directed and motivated, with the ability to work independently with little direction or supervision and in a collaborative environment.
  • Willing and able to perform novel tasks that may be out of the individual’s comfort zone and base knowledge.
  • Attention to detail and thorough in completing work tasks.
  • Ability to plan and organize tasks in order to complete deliverables according to specified timelines.
  • The ability to arrange things or actions in a certain order or pattern according to a specific rule of set of rules. (e.g., pattern of numbers, letters, words, pictures, mathematical operations).
  • This position requires an individual who is flexible enough to meet the changing demands of the organization, who is responsive when called upon for assistance, and who can be relied upon to fulfill requests.
  • This is a hands-on position requiring multitasking, creative out-of-the-box thinking, and commitment to assist in a wide range of quality engineering and RAMS activities.
• Proficient in the following areas:
  • Writing documents.
  • MS Word, PowerPoint, Excel, and Visio.
• Preferred Education, Experience, Knowledge, Skills:
  • Performs visual inspection of mechanical enclosures and cosmetic surfaces.
  • Experience with the calipers, height/depth gages and mechanical drawing interpretation.
  • Proficient with Snagit desired but not required.
  • Familiarity with quality and product assurance (ISO9001, Six Sigma) desired.
• Term: This is a short term assignment, which is anticipated to be up to 8 months.
• Must have permanent authorization for US employment
• To apply and for more detail see http://www.neoninc.org/jobs/QualityInspector

General Information:

• Company: Verify Corporation, Denver, CO
• Hiring: Inspector/Expeditor
• Product: PDC (Power Distribution Center)
• Required Skills:
  • Experience with developing and communicating weekly and daily manufacturing schedule to ensure 100% on time delivery.
  • Experience with managing details of production schedule to maximize productivity of manufacturing and shipping departments.
  • Resolve scheduling conflicts and prioritize customer requirements.
  • Identify and implement appropriate planning, management and control strategies for production, material requirements, inventory levels and shop floor.
  • A Minimum five years as a production controller or planner,
  • CPIM certification is highly desired.
  • Must have computer skills in Microsoft Word, Excel, PowerPoint
  • Must have in-depth understanding of MRP or ERP systems e.g. SAP, MANFACT, SOLUMINA
• Inspection:
  • Must have practical experience performing in-process and final inspections on machined parts, assemblies, and / or sub-assemblies.
  • Must have the ability to read / interpret engineering drawings and Purchase Orders (POs).
  • The candidate must have experience using various mechanical inspection tools, such as micrometers and calipers.
  • Ideal candidate will have a minimum of five years experience performing inspections
• Skills:
  • Looking for someone to go on site approximately 2 times per month (Nov 2013 through Mar 2014)
  • Schedule review and expediting
  • Material availability review and expediting
  • Inspection of PDC to Siemens supplied checklist/inspection plan
• For More information and to apply contact
  • George Hsieh, VSC Program Coordinator
  • Phone: 800-854-7431
  • Email: ghsieh@vscnet.com

General Information:

• Company: MKS Instruments-HPS Products, Boulder, CO
• Hiring: Temporary Quality Inspector Position (6 month temporary assignment)
• Note: Actual hiring will be through a temporary agency
• Required skills
  • Inspector will read product prints and measure key quality features such as dimensions, flatness, surface roughness, concentricity
  • Requires a high level of skill in reading prints, understanding dimensions and tolerances and basic understanding of GD&T
  • Inspector position requires use of height gauges, calipers, roughness testers, ring gauges, test fixtures
  • Ability to use optical comparator and run CMM programs is desirable but not entirely necessary.
  • Should be familiar with inspecting welded parts (particularly TIG welded), and with machined components and surface finish requirements (cosmetic and roughness)
  • Should be familiar with use of AQL based sampling plans, DMR/MRB processes
• Please send resume and salary expectations to:
• Tania Wolanski email: tania_wolanski@mksinst.com

General Information:

• Company: GE Analytical Instruments in Boulder, CO www.geinstruments.com
• Hiring: 3-4 month temporary Quality Engineer to replace engineer going on vacation and maternity leave in late November
• Need: start in next 3-4 weeks to come up to speed before engineer starts leave
• Prefer chemical engineering or analytical chemistry background and quality experience
• Support 2 of our product lines (reference standards and Total Organic Carbon instrument) and would compile and analyze date for each.
• Help identify supplier and manufacturing issues and participate in monthly quality reviews with senior management
• Interested people and for more information contact
• Greg Boothe, Director of Quality, AIMS, GE Power & Water Technologies
  • Office: 720.622.0194
  • Cell: 303.250.7515
  • Email: Greg.Boothe@ge.com

General Information:

• Company: An AreoSpace company in Ft. Collins, CO
• Hiring: long-term contract Mechanical Inspector (pays well)
• Looking for a “long-term high-volume amount” contact precision mechanical inspectors
• Interested people contact Gerry Naugle at phone 303-591-2830 or email gnaugle@earthlink.net