Quality Engineer

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.

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:

Responsibilities

• 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

• 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.

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