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.