Supplier Quality Engineer II

About the role

The Supplier Quality Engineer II will manage finished‑goods contract manufacturing for a robotics surgical technology company. You will ensure that suppliers meet stringent medical‑device quality standards and support continuous improvement across the supply chain.

Key responsibilities

• Qualify and audit new and existing contract manufacturers (CMs) to ensure compliance with GMP and QMS requirements.
• Lead, support, review and approve Supplier Change Requests (SCR) and manage part/process qualification activities.
• Develop, implement and maintain technical quality assurance documents such as MSAs, PPAP, Quality Plans, Control Plans and FMEAs.
• Monitor parts from acquisition through production, resolve supplier‑related issues, and drive cost‑effective quality improvements.
• Maintain a regular auditing schedule and provide performance feedback to suppliers.

Required profile

• Bachelor’s degree in Engineering, Science, Electronics or a related technical field.
• Minimum 4 years of relevant experience (or 2 years with an advanced degree) in supplier quality for medical devices.
• Familiarity with ISO 13485 and 21 CFR 820 standards.
• Ability to work independently on moderately complex projects.

Required skills

• Supplier Change Request (SCR) management
• Validation, TMV, PPAP, SCAPA, QMS
• MSA, Quality Plans, Control Plans, FMEA
• ISO 13485 compliance
• 21 CFR 820 compliance

What we offer

• Competitive hourly rate of $40‑$54 based on experience
• Opportunity to work with cutting‑edge surgical robotics technology
• Professional growth in a regulated medical‑device environment