Supplier Quality Engineer

Overview

Duration: 12+ Months (Possible temp to hire)

Onsite Role

Must be able to travel 5-10% globally (possibly Sweden, China, Finland, also local)

• This role has a wide scope of responsibilities ranging from ensuring supplier design assurance, supplier product development integration assurance, and third-party manufacturing assurance.
• Apply strong engineering fundamentals to analyze supplied designs, assess supplier process capabilities, and drive corrective and preventive actions that enhance quality, reliability, and manufacturability
• 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.
• 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 Cardiac Diagnostics 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.
• Investigating and evaluating suppliers of new and existing technologies for use in future products or to improve quality/reliability of current products.
• Participating in risk assessment of supplier capability, supplier designs and supplier supply processes to support planning and execution including service risk mitigation measures to ensure continuity of supply for CDx

• Bachelor’s degree in engineering or related discipline
• Minimum 5 years of technical experience working in Medical Device development processes
• Experience in design controls, risk management, process validation, and CAPA
• Ability to travel 5-10% globally (possibly Sweden, China, Finland, also local.) Approximately 5-10 trip per yr.

• Design assurance experience with 7+ years working in Medical Device development
• Experience working with suppliers and familiar with the application of design controls and supplier controls as per 21
  
  CFR
  820 and MDR
• Auditor of quality systems experience (ISO 13485 or similar)
• Self-driven and results oriented with strong data analytics and critical thinking skills