Quality Assurance Manager

  • ExtremityCare
  • Conshohocken, PA
  • Quality Assurance
  • Full Time
  • Head of Quality Assurance
  • Exempt
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The Quality Assurance Manager is responsible for ensuring that all products and services meet established quality standards.


Duties & Responsibilities:

  • Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB, other regulations (as appropriate), and industry standards.
  • Author, revise, and maintain procedures/controlled documents according to FDA, AATB, and other applicable regulations.
  • Manage deviations, nonconformances, complaints, CAPAs, SCARs, and safety incidents and ensure timely completion of associated investigations.
  • Ensure adequacy of investigations with respect to root cause analysis and CAPA assessment (as appropriate).
  • Establish, evaluate, report, and provide improvements (where appropriate) for quality metrics.
  • Manage and oversee review of HCT/P donor records for final product release in accordance with standard operating procedures and regulatory/accrediting agency requirements.
  • Manage and oversee review of quality control records to include equipment cleaning, maintenance, environmental monitoring, and supply inspections.
  • Assist with training of processes and corrective actions relating to quality.
  • Support implementation of new projects/product development.
  • Support development of validation/qualification protocols and summary reports in accordance with regulatory requirements and industry best practices.
  • Review and approve validation/verification protocols, execution data, and summary reports.
  • Support internal, client, and regulatory agency audits to ensure compliance with regulatory requirements, certification requirements, and internal policies and procedures.
  • Maintain professional working relationships with customers, partners, and vendors.
  • Manage direct reports and monitor individual performance.
  • Maintain records in accordance with standard operating procedures.
  • Attend/participate in offsite business meetings/conferences.
  • Perform other related duties as assigned.


Skills & Abilities:

  • Leadership & Management skills
  • Attention to detail
  • Organized
  • Verbal/Written Communication skills
  • Analytical Thinking skills
  • Technical Writing skills
  • Multi-tasking skills


Education & Experience:

  • Bachelor’s degree in a biological science or related field required.
  • At least 5 years of experience in quality in an FDA regulated environment for HCT/Ps and/or medical devices (or related field), with progressive management responsibility/experience

Quality Control Manager - Quality Assurance

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