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QA Compliance Manager

  • Job type: Permanent
  • Location: Charleston, South Carolina
  • Salary: US$95000 - US$120000 per annum + Full Benefits
  • Job reference: 274791/002_1551100044
  • Sector: Operational Excellence, DSJ Global
  • Date posted: 25/02/2019

QA Compliance Manager

Location: Charleston, SC

Salary: $95,000-120,000

A leading and international medical devices developer, manufacturer, and marketer is looking to fill their QA Compliance Manager position. The QA Compliance Manager will implement and develop the Regulatory Compliance and Audit program at the BDI site. The successful candidate is also responsible for training and coaching the local audit team members and will function as a subject matter expert in quality and regulatory compliance issues.

What the QA Compliance Manager's Day-to-Day Looks Like:

  • Confirms GAP analyses are performed and any corrective actions are taken
  • Coordinates with the Head of Quality and Plant Management Team to schedule and implement plans for annual regulatory compliance audits
  • Manages the site Internal Audit programs
  • Conducts training, guidance and coaching to the compliance team auditors
  • Integrates comprehensive knowledge of applicable regulatory requirements and their interpretation

The QA Compliance Manager's Should Have the Following Qualifications:

  • B.S. in Science / Engineering or Physical or Biological Sciences.
  • 5+ years quality, compliance and regulatory experience in the Medical Device Industry, Combination Products, Regulatory requirements and/or Pharmaceutical experience preferred
  • 3+ years personnel management experience

Benefits and Perks:

  • 401(k) Plan
  • Employee Stock Purchase Plan
  • Medical, Dental, and Vision Coverage

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