Quality Manager

  • location: Leland, NC
  • type: Permanent
  • salary: $80,000 - $90,000 per year
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job description

Quality Manager

Permanent position: Leading Original Equipment Manufacturer (OEM) of specialty medical products seeks a Quality Assurance and Regulatory Manager for its manufacturing operations located just outside of WILMINGTON, NC. This individual will manage quality assurance, develop and implement quality management procedures and systems, and manage product regulatory compliance. IMMEDIATE OPPORTUNITY WITH A WORLD CLASS ORGANIZATION!

Responsibilities for the Quality Manager
  • Manage Quality Assurance by developing and implementing quality management policies, procedures and systems for product lines
  • Monitor product conformity to specifications, certify and issue certificates of conformity
  • Ensure that all departments are in compliance with all applicable standards including FDA, ISO 13485, and European Medical Device Directive
Requirements for the Quality Manager

  • BS/BA degree with at least 3-5yrs QA/Compliance related work and supervisory experience in a FDA regulated manufacturing environment
  • Demonstrated knowledge of ISO 13485, QSR 21 CFR Part 820 regulatory requirements
  • Strong project management, organizational, and communication skills
Benefits

  • Competitive benefits package, to include medical, dental, 401k plan
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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