Quality Assurance Manager


A NH manufacturing company is in search of a Quality Assurance Manager to join their team! In this role you will be responsible for the entire quality function of a busy, multi shift manufacturing operation. The qualified candidate should have a working knowledge/experience with FDA QSR/GMP and ISO 13485:2003 quality systems.

Responsibilities:

  • Inter-department interaction with Engineering; Manufacturing; Purchasing; Inventory Control
  • Communicate and resolve Internal, Customer and Vendor Quality Issues
  • Responsible for ISO Standard Update/Implementation from ISO 13485:2003 to ISO 13485:201
  • Responsible for the CAPA Syste
  • Responsible for the Calibration System
  • Administration of NCR; serve as Material Review Board Lead Member
  • Involvement with Employee Training
  • Directly Support both Customer, ISO and FDA Audits
  • Serve as ISO Management Representative
  • Documentation (CAR/DOE/Work Instructions/Test Procedures etc.)
  • Administration of activities associated with Customer Returns
  • Administration of product sterilization and bio burden
  • Supervision of Quality Control Inspectors and Quality Assurance Cler
  • Act as QA signature authority (ECNs, Deviations, C of C etc.)
  • Serve as a team member on Design Development Projects
  • Author and maintain quality system Standard Operating Procedures
  • Lead Internal Audit Team-schedule, execution and related follow up of activities
  • Serve on Management Review Team, responsible for meeting minutes

Qualifications

  • The qualified candidate should have a working knowledge/experience with FDA QSR/GMP and ISO 13485:2003 quality systems
  • Four-year undergraduate degree + five to eight-years prior QA/QC supervisory/management experience, preferably in the medical device industry

Hours:

  • 1st Shift | Mon-Fri | 8:00am-5:00pm
  • Generous benefit package

Pay Rate:

  • $70,000-$80,000 annually based on experience

Use the boxes below to fill out a simple job application. Your recruiter will contact you quickly to go over your information and schedule an interview to see if you qualify for this or other positions.

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