Supplier Quality Engineer

Job Title: Principal Supplier EngineerDuration: 12+ Months (Possible temp to hire)Location: Arden Hills, MN 55112Onsite RoleMust be able to travel 5-10% (approx. 5-10 trip per yr.); destinations may include European countries, China and within the US. Responsibilities: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 manufacturabilityWorking 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.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 CDxCoordinating all phases of supplier engineering work including content for projects and communicating emerging issues and recovery plans with site leadership and stakeholders to gain resources and supportDemonstrating a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and proceduresEducation/Experience:Bachelor’s degree in engineering or related disciplineMinimum 8 years of technical experience working in Medical Device development processesExperience in design controls, risk management, process validation, and CAPAAbility to travel 5-10% (approx. 5-10 trip per yr.); possibly destinations include EU countries, China and within the US).Preferred:Design assurance experience with 10+ years working in Medical Device developmentExperience working with suppliers and familiar with the application of design controls and supplier controls as per 21CFR820 and MDRAuditor of quality systems experience (ISO 13485 or similar)Self-driven and results oriented with strong data analytics and critical thinking skills