What are the responsibilities and job description for the Senior Supplier Quality Engineer - Medical Devices (Hybrid) position at System One Holdings, LLC?
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 :
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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