Our client, a Global Medical Device Manufacturer,?has an immediate opening for a Quality Engineer on a?6-month contract. Our client offers results-driven people a place where they can make a difference ? every day! ?You will also have the opportunity to work with other like-minded, self-directed, and detail-oriented Top Talents in an extremely collaborative and professional environment. ?

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The regional NPI QE team as part of GQO Quality Assurance organization with responsibility for quality assurance activities, including, but not limited to the following:
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Responsibilities

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• Collaborating with R&D, AO & GQO throughout the NPI and overall product lifecycle.
• Driving Process Risk Management activities.
• Developing Effective Inspection processes.
• Acting as Validation Quality Approver and, where certified, Validation Rep/Specialist.
• Driving Process Excellence, pursuing validation over verification, where appropriate.
• Owning the NPI Purchasing Controls via PPAP and related efforts.
• Designing and transferring designs and processes, as well as project transfers.
• Fostering collaborative internal/external professional relationships across Design Divisions, Advanced Operations & GQO functions related to design transfer activities.
• Communicating effectively with all internal customers, stakeholders, and project teams to ensure successful project transfers that meet NPI goals.
• Mentoring other groups on areas of expertise, with particular focus on design and process transfer.
• Applying effective risk management practices and tools, with high expertise in failure modes associated with production (PFMEA).
• Supporting the Risk Management File through application of risk management principles.
• Evaluating process risks, implementing risk mitigation strategies, and ensuring appropriate process controls are identified, qualified, and deployed throughout the product lifecycle.
• Ensuring all Risk Management outputs comply with ISO 14971.
• Supporting the design team to complete CQA/CTQ identification and inputs to dFMEA.
• Implementing lean inspection strategies and inspection plans utilizing state-of-the-art methods and technologies.
• Ensuring inspections are repeatable, efficient, and scalable.
• Leading the continuous improvement of inspection methods and sampling plans, with a focus on eliminating human error risks.
• Leading First Article Inspection (FAI) strategies internally and externally, and approving First Article Inspections.
• Optimizing inspection costs through lean initiatives while maintaining safety, integrity, and product reliability.

Requirements

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• B.S. in Engineering, Physical Sciences, or Statistics; M.S. preferred.
• Minimum of 3 years of professional experience post-academia in quality engineering roles.
• Proven ability to collaborate effectively with R&D, Operations, and GQO teams.
• Strong expertise in Process Risk Management, PFMEA, and developing inspection processes.
• Experience with validation activities and driving process excellence.
• Certified Validation Approver and experience as a Validation Rep/Specialist.
• Hands-on experience with PPAP and purchasing controls.
• Background in validation protocol development and execution.
• Experience working for companies such as Edwards Lifesciences, Masimo, MicroPort, Confluent Medical, Medical/Device manufacturing, or similar sectors.