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Process Quality Engineer

Boston, MA 01810

Industry: Quality Assurance Job Number: 2020

Position Summary:

Our client. is currently looking for a highly motivated Process Quality Engineer to join our team and help revolutionize transplant medicine.  Based at our headquarters, this is a hands-on role in a fast-paced and dynamic medical device company.

Position Responsibilities:

  • Support day-to-day manufacturing activities.
  • Lead efforts to identify and resolve manufacturing non-conformances (containment, root cause investigation, corrective action).
  • Support process validation activities.
  • Support new product development programs.
  • Support/lead investigations of complaints due to manufacturing defects.
  • Support internal audit and manufacturing GMP/ISO 13485 audit programs.
  • Lead/assist with manufacturing Corrective and Preventive Actions (CAPA).
  • Identify product and process improvements; lead or support their implementation.
  • Create production documentation including manufacturing, inspection and test instructions.
  • Support training program for production team and quality inspectors.
  • Perform other tasks and duties as required.

Position Requirements:

  • BS in Engineering or related discipline with 5-10 years of experience as a Quality/Manufacturing Engineer in the medical device manufacturing industry including 2+ years supporting manufacturing of consumable/disposable products.
  • Thorough knowledge and understanding of FDA QSR and ISO 13485 regulations.
  • Experience in medical device manufacturing and EtO sterilization of disposable medical devices.
  • Experience leading or supporting process validation activities.
  • Thorough understanding of basic statistics and experience using Minitab (or similar statistical software packages).
  • Ability to define problems, collect and analyze data, and draw valid conclusions.
  • Ability to communicate ideas and information clearly, effectively and concisely.
  • Highly detailed oriented with strong organization and prioritization skills.
  • Must possess a high level of energy with the ability to handle multiple projects and changing priorities.
  • Must be results-driven and exhibit a sense of urgency.
  • Lean Six Sigma training/certification is a plus.






Arshad Alam

Arshad is a seasoned recruiter in the healthcare space with over 15 years of experience in promoting career growth for healthcare professionals. He has played a critical role in the launch of several startup companies. He is known for versatility and leadership; expert in overseeing high-level priorities and a broad range of responsibilities.

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