Supplier Quality Engineer - Robotics Surgical Technologies
North Haven, CT | Onsite
Join a team supporting advanced robotic surgical technologies where your supplier quality expertise will directly impact innovative medical device products.
Key Responsibilities:- Lead and support Supplier Change Requests (SCR), validation, TMV, PPAP, SCAPA, and QMS activities.
- Develop, implement, and maintain Quality Plans, Control Plans, FMEAs, and other supplier quality systems.
- Qualify and monitor suppliers to ensure compliance with quality and GMP requirements.
- Resolve supplier quality issues from acquisition through manufacturing.
- Conduct supplier audits and evaluate supplier performance.
- Drive technical quality, process, and cost improvements with CMs and suppliers.
- Partner with internal teams and external suppliers to ensure quality requirements are met.
Required Qualifications:- Bachelor's degree in Engineering, Scientific, Electronics, or a related technical field.
- 4+ years of relevant experience (or advanced degree with 2+ years).
- Experience with medical device quality systems and regulations, including ISO 13485 and 21 CFR 820.
- Strong experience with supplier quality, PPAP, validation, FMEA, Control Plans, and QMS.
- Ability to work independently and collaborate effectively with cross-functional teams.
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