Principal Supplier Quality Engineer

Roles & Responsibilities

• Working with Medical Device OEM, sub-system and component suppliers to identify supplier specifications with the end goal of successfully integrating supplied designs and components into CDx's development and manufacturing processes.
• Pricing with R&D, Design Assurance, Manufacturing Engineering, Operations Quality, and Project Management to execute supplier control deliverables according to program needs, such as purchased material qualifications, supplier-driven change assessments, supplier design or capability improvement projects, or regulated compliance assessments.
• Generating and reviewing quality plans, agreements, product specifications, component qualifications, design verification/validations, and process validations.
• Investigating complaints and managing supplier investigations for both design and manufacturing-related issues.
• Participating in supplier audits to assess design and manufacturing compliance to regulatory standards and CDx agreed specification requirements. Audit activities include the evaluation of audit observations and findings, reporting, follow-up, and confirmation of follow-up actions.
• Acting as a technical expert to ensure repeatable and reproducible quality/reliability during the life of the product.

Requirements

• Bachelor's degree in engineering or related discipline.
• 7+ years of technical experience working in Medical Device development processes.
• Experience in design controls, risk management, process validation, and CAPA.
• Design Assurance experience.
• Component and supplier qualification experience.
• Strong Project Management skills.
• Auditor of ISO 13485 quality systems (ISO 13485 Certified Auditor preferred).
• Self-driven and results oriented with strong data analytics and critical thinking skills.
• Experience managing projects and working with cross-functional teams to drive deliverables.
• Experience working with suppliers and familiar with the application of design controls and supplier controls as per 21CFR820 and MDR.
• Supplier design assurance, supplier product development integration assurance, and third-party manufacturing assurance.