Sr. Quality Engineer - Medical Devices

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Our client, a leading Medical Device company, is seeking an experienced Quality Engineer to join their growing team - see below for other details!

• Risk Management (Hazard Analysis, DFMEA, UFMEA)
• Design Verification Authoring and Execution

• The Senior Quality Engineer position on the team supports new product development for Surgical Instruments.
• In this role, the Senior Quality Engineer works as part of the quality team supporting the cross-functional core team.
• An understanding of mechanical and electromechanical design, design verification, design validation, process validation, risk management and complaint analysis is preferred.
• As an important member of our Quality Team, you will provide guidance and implement strategies that drive product quality and continuous improvement.
• Actively participate in product development cycle by reviewing mechanical/electromechanical project documentation, participating in product risk assessments, and working closely with Product Development to develop appropriate verification and validation testing requirements.
• Assesses overall product risk by facilitating the development of risk management tools such as the risk management plan/report, hazard identification, risk analysis chart, complaint analysis, etc.
• Collect, analyze and interpret statistical data. Performs analyses and provide reports to management as required.
• Contributes to the successful completion of Design and Process Validation initiatives by planning/reviewing validation and qualification activities, as required. This may include oversight to System/Sub-system Requirements, Critical to Quality Matrix, Process Flows, Control Plans, Measurement Systems Analyses and Process Capability Analyses.
• Assisting with projects and assuring proper and consistent implementation of the quality engineering tools.
• Provide solutions to a wide range of difficult challenges. Work independently to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives.

4+ years of experience within Quality Engineering in a regulated environment

Bachelor's Degree within an Engineering realm

NICE TO HAVE

• ASQ Certified Quality Engineering (CQE)
• Knowledge of and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO
  13485, 14971 and 60601 requirements
• Understanding of software and hardware interface

• Seniority level:
  Mid-Senior level
• Employment type:
  
  Contract
• Industries:
  Biotechnology Research and Medical Equipment Manufacturing

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