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Job

NPI Quality Engineer

  • Job ref:

    12727

  • Location:

    Manchester, United States

  • Sector:

    Quality Engineers

  • Contact:

    Bob Giusti

  • Published:

    7 months ago

  • Consultant:

    #

NPI Quality Engineer

 

Support design transfer activities and quality operations in an innovative, fast-paced, medical device-manufacturing environment. This role includes generation of project plans, risk management files, validation protocols, and other QMS documentation (assessments, enrollment forms, etc.) to support initial qualification and launch of commercial production activity.

Responsibilities:

  • Leverage your engineering and technical experience to ensure compliance with applicable regulatory standards throughout the New Product Introduction process
  • Develop inspection procedures and sampling plans for new production, continuous improvement of process controls, and improved workflow/worker satisfaction
  • Assist in the development, implementation, and approval of Device Master Records, Device History Records, and Risk Management Files for new products
  • Lead the evaluation and identification of validation requirements and sampling plans for new, and changes to, manufacturing processes, test methods, and equipment
  • Lead project teams through protocol generation, execution, documentation organization, report writing, etc. while meeting schedule for final approval and release for use
  • Lead investigations resulting in root cause and corrective actions through use of data analysis, inductive and deductive reasoning, and problem solving skills
  • Provide guidance and assistance on the assessment of new and changes to existing manufacturing equipment, ensuring proper enrollment into QMS systems and that Validation requirements are met
  • Participate in Material Review Board (MRB) meetings, track and follow through with non-conformance reports assigned

Requirements:

  • Candidate must have a B.A. or B.S. degree; equivalent experience in relevant technical fields will be considered
  • At least 3 years of experience in Medical Device Manufacturing or other similarly regulated industry such as Aerospace, Military, etc.
  • Strong knowledge of CFR Part 820 and ISO 13485 required
  • Lean and Six Sigma certification strongly preferred
  • Strong knowledge of IQ/OQ/PQ requirements and supporting engineering specifications
  • Knowledge of New Product Introduction processes and deliverables
  • Strong knowledge of tolerance stack up calculations and calibration best practices

 

 

 

 

 

 

 Some clients require proof that temporary associates have received all required doses of the COVID-19 vaccine by their first date of employment, unless a reasonable accommodation recognized by law is approved. To request an accommodation, please email hr_us@staffing360solutions.com.