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Job

Quality Manager

  • Job ref:

    10903

  • Location:

    Watertown, United States

  • Sector:

    Quality Engineers

  • Contact:

    Lissa Jerez

  • Published:

    18 days ago

  • Consultant:

    Lissa Jerez

Responsibilities

  • Maintaining compliance status of the company with respect to quality system certifications to ISO 13485:2016.
  • Maintaining and enhancing processes to ensure quality system compliance with the FDA Quality System Regulation.
  • Will be the ISO Management Representative and MDR Person.
  • Oversees the scheduling, performance and responses to internal and external audits.
  • Manages the company CAPA system.
  • Leading Management Review meetings.
  • Overseeing, maintaining, and creating Quality System documentation and regulatory files.
  • Reviewing and approving validation activities.
  • Leading Incoming Inspection, Document Control and Supplier Quality functions.

 

Qualifications / Experience Requirements

  • Minimum of 5 years as a manager of QA/RA at a medical manufacturing company.
  • Working knowledge of FDA Quality Systems Regulation and other countries may be necessary.
  • Experience with specific devices containing hardware and software components.
  • Excellent communication, interpersonal, time management, and leadership skills.
  • We require someone willing to roll up their sleeves to get things done and not merely to pontificate and/or to direct the actions of others.
  • Bachelor's Degree in Engineering.