Quality Control Supervisor

Purpose:

The Quality Control Supervisor leads the quality inspection team. This position coordinates and performs quality control processes; executes sound quality policies to ensure safety and quality of products; and performs other related other duties as required.

Duties & Responsibilities:

• Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB, other regulations (as appropriate), and industry standards
• Author and revise procedures/controlled documents according to FDA, AATB, and other applicable regulations
• Support development of validation/qualification protocols and summary reports in accordance with regulatory requirements and industry best practices
• Assures adequate sampling plans, and inspection procedures are implemented
• Maintains quality indicators and respective reports/ presentations
• Assist with deviations, nonconformances, complaints, CAPAs, SCARs, and safety incidents and ensure timely completion of associated investigations
• Oversee incoming inspection of HCT/Ps and medical devices in accordance with standard operating procedures and regulatory/accrediting agency requirements
• Sort and segregate acceptable and unacceptable HCT/P products and/or medical devices
• 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
• Oversees the product release to ensure that safe and e?ective product is distributed to customers. Responsible for approval or rejection of components, ?nished products, and documents to achieve this purpose
• Directs the activities of the Quality Control team
• Owner of process controls and non-conforming product
• Report to work in-person and start job duties on time for established shift
• Complete required hours on assigned works shift to complete assigned responsibilities and duties

Skills & Abilities:

• Ability to analyze information and act on results
• Ability to work well with people at all levels within the organization
• Accuracy and attention to detail
• Ability to secure and maintain a favorable background investigation and clearance

Education & Experience:

• A minimum of a bachelor’s degree in science, engineering, other relevant discipline; minimum of 3 years’ experience working in an FDA or ISO regulated environment; or equivalent combination of education and experience