Quality Assurance Engineer

Our client, a Global Medical Device Manufacture has an immediate opening for a Quality Assurance Engineer for 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. 

Position Description (Principle Duties and Responsibilities)

The experienced Quality Engineer will be responsible for supporting and executing designs for manufacture and assembly through technical leadership in quality assurance, design control and preventative activities.

Day-to-Day Duties May Include:

• Supporting the development and introduction of new products, processes, and technologies, with a focus on quality systems development, regulatory compliance, and process risk management including pFMEA.
• Supporting the development and characterization of processes that are capable, scalable and produce high yield.
• Supporting the design of robust inspection strategies including CQA's, CTQ's and MSA's to enable process risk identification, process characterization, capability and robust process control.
• Providing quality engineering support for the execution of quality assurance activities during design transfer phases of new product development.
• Providing quality engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with new product development procedures.       
• Ensuring all risk management outputs comply with ISO14971.
• Supporting the design team to complete CQA/CTQ identification and inputs to dFMEA.
• Developing and implementing lean inspection strategies and inspection plans through state-of-the-art inspection methods and technologies.
• Ensuring inspections are repeatable, efficient, and scalable.
• Developing Measurement System Analysis (MSA) strategy and approving executed MSAs.
• Supporting the development, execution, and approval of validation strategies, with the goal of highly capable processes that result in high yield and enable scalability.
• Approving protocols and reports, including data analysis.
• Supporting the supplier qualification strategy and approve the supplier validations and Production Part Approval Process (PPAP).
• Supporting implementation of supplier certification.

Qualifications:

• Bachelor's Degree in Engineering required.
• 6 years' engineering experience required
• Proficient in risk management practices and tools.
• High expertise in failure modes associated with production and production related processes, (PFMEA).