Director of Quality Assurance

4 weeks ago


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

The Director of Quality Assurance 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. This role is responsible for defining and promoting a quality mindset throughout the organization, developing and implementing procedures, and providing subject matter expertise to drive improvements and decisions relating to the quality management system.

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
* 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)

Requirements

* 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 experience 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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