Quality Engineer - Full-time / Part-time

Aerotek is in search of a Quality Engineer to join a well-established team in Broomfield, CO. This is a 6 month contract. This position requires a 4 year Bachelor's Degree. The ideal candidate will have experience in a regulated industry and CAPAs. Please review the job description below and apply if qualified/interested.

Reviews new and modified product designs for quality characteristics, including manufacturability, measurability, and conformance to regulatory requirements
When assigned as a member of a product development team, coordinates with other Quality and Regulatory Affairs staff to ensure that the product is developed in compliance with company quality system requirements and is successfully transferred to ongoing operations
Defines and ensures implementation of measurement methods to verify that products and components meet specified requirements
Provides support to the Supplier Quality Engineer to ensure the rapid resolution of quality problems in manufacturing and with suppliers
Leads the Material Review Board (MRB), ensuring timely analysis, disposition, and investigation of product non-conformances and equipment removed from service
Facilitates the validation of manufacturing equipment and processes
Works with all Quality and Regulatory Affairs areas to ensure that assigned products under development meet quality system requirements, meet applicable international regulatory requirements, have required measurement equipment available when needed, and have appropriate inspection items identified and documented for Company and supplier use.
Works with new product development teams on assigned products and projects to ensure that design control requirements are met, including but not limited to product risk analysis, design verification, and design validation.
Participates in Corrective Action and Preventive Action (CAPA) projects and activities as assigned.
Reviews new and modified product designs for quality characteristics, including manufacturability, measurability, and conformance to regulatory requirements.
As assigned, works with Complaint Coordinators to investigate and respond to customer complaints and customer feedback on assigned products.
As required, works with the Supplier Quality Engineer in the Supplier Quality process, including NCR follow-up, required SCAR actions, quality-related communications, and metrics.
Works with Inspection Services to ensure incoming material conformance to specifications.
Completes Root Cause Analysis when required to eliminate defined problems or issues.
If necessary, stops or postpones manufacturing of products if quality concerns exist.
As assigned, establishes quality management system elements that comply with 21 CFR part 820 and ISO 13485 requirements.
Designs, completes and/or assists in gage repeatability and reliability studies, as necessary.
Compiles and analyzes quality trending information as required.
Provides training to company employees on quality system elements and quality tools as required
Leads the Material Review Board (MRB), ensuring timely analysis, disposition, and investigation of product nonconformances and/or product removed from service after return.
As assigned, defines and ensures implementation of measurement methods to verify that products and components meet specified requirements.
Assists in external audits of Biomet Spine performed by regulatory agencies.
Facilitates the validation of Manufacturing equipment and processes, as assigned.

About Aerotek:

Aerotek, headquartered in Hanover, Md., is a leading provider of technical, professional and industrial staffing services. Established in 1983, Aerotek is an operating company of Allegis Group, the largest provider of staffing services in the U.S. Aerotek operates a network of more than 200 non-franchised offices throughout the U.S., Canada and Europe. For more information, visit .

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 844 895-8598 or email . However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.