Senior Supplier Quality Engineer

We are seeking an experienced Senior Supplier Quality Engineer to support new product development, supplier quality controls, and design transfer activities within a regulated medical device environment.

This individual will serve as the supplier quality representative on cross-functional project teams, partnering with R&D, Manufacturing, Regulatory Affairs, Component Engineering, and Supply Chain. The role requires strong technical judgment and the ability to influence quality decisions without direct authority.

Key Responsibilities

• Provide Supplier Quality Engineering support throughout the new product development lifecycle.
• Support the transfer of new products, components, and manufacturing processes to suppliers.
• Ensure purchased components are qualified according to applicable quality, regulatory, and customer requirements.
• Partner with suppliers and internal teams on supplier changes, nonconformances, investigations, and CAPA activities.
• Lead or support supplier qualification, auditing, validation, and ongoing performance monitoring.
• Collaborate with Component Engineering to establish product acceptance and sampling strategies.
• Develop and review control plans, receiving inspection requirements, and supplier quality documentation.
• Define internal test requirements and support test method validation.
• Coordinate Approved Supplier List activities and supplier-owned quality initiatives.
• Apply risk-management principles throughout product development and sustaining activities.
• Drive continuous improvement initiatives related to supplier quality, component reliability, and manufacturing performance.
• Provide technical guidance, coaching, and quality leadership to project teams and less-experienced colleagues.

Required Qualifications

• Bachelor’s degree with at least 4 years of relevant experience; or
• Master’s degree with at least 2 years of relevant experience; or
• PhD with relevant academic or industry experience.
• Experience supporting new product development, new product introduction, or design transfer to external suppliers.
• Experience managing supplier changes, nonconformances, investigations, and CAPA activities.
• Knowledge of supplier qualification, process validation, risk management, and quality-system requirements.
• Strong analytical, communication, collaboration, and influencing skills.
• Ability to lead cross-functional quality initiatives without direct reporting authority.
• Ability to work independently, manage complex assignments, and recommend process improvements.

Preferred Qualifications

• Experience within the medical device or another highly regulated industry.
• Knowledge of ISO 13485, FDA 21 CFR Part 820, GMP, and applicable supplier-control requirements.
• Experience with control plans, sampling plans, receiving inspection, test method validation, and supplier audits.
• Experience working with contract manufacturers and component suppliers.
• Familiarity with NPI/NPD quality tools, CAPA, NCR/NCMR, FMEA, PPAP, MSA, and process validation.