Quality Assurance Manager

3 weeks ago

San Antonio, United States Extremity Care Full time
Job DescriptionJob DescriptionSalary: From $70, 800.

Purpose:

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 standards, cGMP/CGTP, and other organizations policies and procedures.
  • Author, revise, and maintain procedures/controlled documents according to FDA, AATB, and other applicable regulations.
  • Manage processes and efficiency in department to support organizational strategic objectives.
  • Establish, evaluate, report, and provide improvements (where appropriate) for quality
  • 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
  • Support development of validation/qualification protocols and summary reports in accordance with regulatory requirements and industry best practices.
  • Review and approve qualification/ validation/verification protocols, execution data, and summary
  • 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
  • Manage direct reports and monitor individual
  • Maintain records in accordance with standard operating
  • Attend/participate in offsite business meetings/conferences.
  • Starting your job duties on time, staying on the job throughout the assigned shift to complete duties properly, and attending all scheduled meetings and appointments
  • Perform other related duties as


Skills & Abilities:

  • Leadership & Management skills
  • Attention to detail
  • Organized
  • Verbal/Written Communication skills
  • Analytical Thinking skills
  • Technical Writing skills
  • Multi-tasking skills
  • Ability to secure and maintain a favorable background investigation and clearance


Education & Experience:

  • Bachelor’s degree in a biological science or related field
  • 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


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