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Jobs or company...

Quality Assurance Manager

Salary undisclosed
Checking job availability...
Original
Simplified

Our client is an industry/global leader in the development and manufacturing of medical devices. They are seeking a Quality Assurance Manager to join their growing team!

Pay: $80k-$90k/yr

Shift:

  • Monday- Friday
  • 1st shift

Responsibilities

  • Manage overall Quality System to include, but not limited to, audits, CAPAs, document control, risk management, and continuous improvement.
  • Supervise Quality Control functions.
  • Perform product release functions.
  • Assist in operational SOP revisions and maintenance.
  • Assist in the development of validation protocols.
  • Manage communications with the FDA and other regulatory bodies as needed.
  • Assist other areas of site operations as needed.
  • Act as management representative.
  • Manage eQMS database.

Requirements

  • B.S. in Chemistry, Biology, or equivalent.
  • Minimum 5 years in QA Management.
  • Regulatory knowledge of medical devices.
  • Knowledge and understanding of 21CFR Part 820 – QSR, 21CFR Part 210 & 211, ISO 13485:2016, ISO14971:2012, ISO9001:2015.

This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

Our client is an industry/global leader in the development and manufacturing of medical devices. They are seeking a Quality Assurance Manager to join their growing team!

Pay: $80k-$90k/yr

Shift:

  • Monday- Friday
  • 1st shift

Responsibilities

  • Manage overall Quality System to include, but not limited to, audits, CAPAs, document control, risk management, and continuous improvement.
  • Supervise Quality Control functions.
  • Perform product release functions.
  • Assist in operational SOP revisions and maintenance.
  • Assist in the development of validation protocols.
  • Manage communications with the FDA and other regulatory bodies as needed.
  • Assist other areas of site operations as needed.
  • Act as management representative.
  • Manage eQMS database.

Requirements

  • B.S. in Chemistry, Biology, or equivalent.
  • Minimum 5 years in QA Management.
  • Regulatory knowledge of medical devices.
  • Knowledge and understanding of 21CFR Part 820 – QSR, 21CFR Part 210 & 211, ISO 13485:2016, ISO14971:2012, ISO9001:2015.

This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!