Job Description

Job Title: Senior Supplier Quality Engineer – Medical Devices

Location: Lakewood, CO (Hybrid: 2-3 days onsite)

Salary: Depending upon experience, will consider relo reimbursement for the right candidate!

Position Overview:
Join our team as a Senior Supplier Quality Engineer in the medical device industry ! This key role involves managing supplier quality programs, conducting audits, resolving issues, and ensuring compliance with ISO 13485 and FDA QSR . You will drive continuous improvement, support supplier development, and collaborate across teams to ensure the consistent delivery of high-quality components.

Responsibilities:

• Develop and implement supplier quality programs compliant with industry regulations.
• Conduct audits and assessments to ensure supplier quality systems meet standards.
• Resolve quality issues and implement CAPA (Corrective and Preventive Actions).
• Support supplier selection, qualification, and ongoing management.
• Collaborate with cross-functional teams in new product development and lifecycle management.
• Monitor supplier performance and present improvements.

Qualifications:

• Bachelor’s degree in Engineering or a related field (advanced degree preferred).
• 6+ years in Supplier Quality Engineering within the medical device industry .
• Strong knowledge of FDA , ISO 13485 , and ISO 9001 standards.
• Experience with supplier audits and root cause analysis .
• Willingness to travel domestically and internationally .

Why Join Us?

• Competitive salary + 7% bonus.
• Flexible hybrid work schedule.
• Comprehensive benefits including health, dental, vision, 401(k) matching , and more.

Keywords: Supplier Quality Engineer, Medical Device, ISO 13485, FDA QSR, CAPA, Supplier Development, FDA Compliance, Audits, Risk Management, Cross-Functional Collaboration, Root Cause Analysis.



If you have monitored supplier quality for these types of components or similar this position may be a great fit for you!  Please share details in cover letter or try to have some details on your resume.

Plastics : PVC, polypropylene, polyethylene, polystyrene, polyurethane, silicone, and TPE are common for flexible tubing, bags, and other fluid-handling devices.

Metals : Stainless steel, aluminum, titanium, and copper are used in durable, structural, or conducting components like centrifuge rotors, needles, and control units.

Glass : Used in bioreactors, microfluidic devices, and some filtration components due to its chemical resistance and clarity.

Specialty Polymers : For specific applications like microfluidic devices, bioreactors, and sensors, materials like PDMS or nylon are used for their precise characteristics.

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