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:
Qualifications:
Why Join Us?
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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