Director of Quality Assurance and Compliance

1 month ago

San Antonio, Texas, United States Extremity Care Full time
Job Summary

The Director of Quality Assurance and Compliance will oversee the quality management system and ensure compliance with established standard operating procedures, FDA regulations, AATB Standards, and other application regulations and industry standards.

Key Responsibilities
  • Define and promote a quality mindset throughout the organization.
  • Develop, implement, and maintain procedures and controlled documents according to FDA regulations, AATB Standards, and other applicable regulations.
  • Provide subject matter expertise to drive improvements and decisions relating to the quality management system while supporting organizational strategic objectives.
  • Oversee management of change control, the document change system, design control, record control, and periodic review of controlled documents and perform associated quality approvals.
  • Lead training of new processes, process revisions, and corrective actions relating to quality.
  • Oversee management and coordination of training requirements/assignments.
  • Oversee management of quality operations to support production and distribution.
  • Manage and oversee review of quality control records to include equipment cleaning, maintenance, environmental monitoring, and supply inspections.
  • Oversee management of 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.
  • Conduct quality review and approval for closure of deviations, nonconformances, complaints, CAPAs, and SCARS.
  • Lead risk management of department and ensure risks/issues are identified, addressed/reported, and where appropriate, escalated.
  • Oversee, lead, and manage quality system related meetings including management review.
  • Establish, evaluate, report, and provide improvements (where appropriate) for quality metrics.
  • Collaborate with Product Development/Management to establish and support project timelines.
  • Provide quality oversight, support, and approval for new projects and products.
  • Collaborate, review, and approve validation/verification/qualification plans, protocols, execution data, and summary assessments.
  • Oversee and manage use of quality system software(s).
  • Direct, participate, and/or support internal, client, and regulatory agency audits to ensure compliance with regulatory requirements, accreditation/certification requirements, and internal policies and standard operating procedures.
  • Develop and maintain professional working relationships with current and potential customers, consultants, suppliers, and vendors.
  • Establish and execute continuing education strategy for department.
  • Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures.
  • Manage direct reports.
  • Provide constructive feedback and guidance to develop leadership in direct reports and department management.
  • Establish and monitor objective annual goals for direct reports.
  • Conduct performance reviews and establish performance improvement plans as needed.
  • Recruit, interview, and select personnel for hire.
  • Travel domestically up to 20% to attend offsite meetings, conferences, and support business initiatives.
  • Start job duties on time, stay on the job throughout the assigned shift to complete duties properly, and attend all scheduled meetings and appointments.
  • Work outside normal business hours during weekdays and on the weekend as needed to support business/operational needs.
  • Perform other related duties as assigned.
Requirements
  • Excellent attention to detail and organization.
  • Excellent written and verbal communication.
  • Highest level of ethics and integrity.
  • Ability to lead and motivate the right behaviors.
  • Ability to multi-task and work in a fast-paced environment.
  • Proficiency in Microsoft Office.
  • Bachelor's degree in a biological science, engineering, or related field required.
  • Master's degree in a biological science, engineering, or related field preferred.
  • At least 5-7 years of in an FDA regulated environment for HCT/P, medical device, and/or pharmaceutical manufacturing, with progressive management experience in quality and/or regulatory affairs required.
  • Clearance of favorable background investigation required.

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