Supplier Quality Engineer II – Medical Device

About the role

The Supplier Quality Engineering II role supports the Supplier Quality Engineering team in day‑to‑day activities on shift C, ensuring that supplier processes meet regulatory standards and the company’s Quality Management System. You will work closely with suppliers, internal R&D, and cross‑functional teams to drive quality and compliance for medical device components.

Key responsibilities

• Support execution of activities to comply with regulatory standards and QMS requirements for supplier quality.
• Conduct technical reviews of suppliers to assess capability for material production.
• Oversee assessment, monitoring, and continuous improvement of supplier manufacturing, process, and quality control practices.
• Define and approve PPAP requirements for new and revised purchased parts and track on‑time completion.
• Issue and follow up on SCARs, SACAs, and NCEs, ensuring workflow timing meets client KPIs.
• Collaborate with suppliers on root‑cause analysis, applying metrology and statistical measurement to resolve issues.
• Work with Post‑Market Surveillance, Quality Engineering, Manufacturing Engineering, and R&D to address supplier‑related complaints.
• Resolve day‑to‑day quality issues, manage non‑conformities, and coordinate containment actions.
• Maintain complete supplier quality records, including performance indicators and certifications.

Required profile

• Experience in supplier quality engineering or related quality assurance functions.
• Familiarity with regulatory standards and Quality Management System processes.
• Ability to conduct technical supplier reviews and manage PPAP documentation.
• Proven capability to work collaboratively across functional teams and with external suppliers.

Required skills

• Metrology and statistical measurement techniques.
• PPAP (Production Part Approval Process) management.
• First Article Inspection procedures.
• Handling of SCAR, SACA, and NCE quality reports.