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Quality Assurance/Auditor Coordinator

Larry Radzely East Hanover ,NJ
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

The company is a manufacturer of medical instrumentation.  This position plays a very important role in the company's compliance with quality system regulations.  Responsible for complaints, CAPA, Vigilance, and recall processes.  

Benefits:

  • Fully paid family medical
  • Dental
  • Life Insurance
  • 401K
  • Vacation, PTO, and paid holidays
  • Tuition Reimbursement
  • Annual bonus

Responsibilities:

  • Quality & Compliance in the areas of complaint evaluation, documentation, MDR/MPR, and recall processes.
  • Accurate reporting of all U.S. MDRs and Canadian MDPRs.
  • Timely completion of CAPA/IMS issues.
  • Support the Quality & Compliance team during external audits / inspections.
  • Execution of the complaint’s evaluation process.
  • Assist with the tracking & metrics required for the Management Review Process.
  • Company's primary interface with the FDA and Health Canada when complaints require written reporting.
  • Work closely with ASA, Q&C, and company Hotline in responding to complaints.

 

Qualifications:

  • A Bachelor's degree in Engineering, Science, or related discipline is required (Master's Degree is a plus).
  • Minimum of 5 year’s experience in medical device quality, or quality systems.
  • Strong knowledge in medical device and FDA regulations.  ISO experience is a plus.
  • ASQ or similar certification are a big plus.
  • Up to 10% travel could be required.
  • This position is not eligible for sponsorship for work authorization. Therefore, if you require sponsorship to work in the U.S., we cannot consider your application at this time.

Larry Radzely

Address

East Hanover, NJ
07936 USA