Quality Control Supervisor (Distribution)
Extremity CareConshohocken, PA, US30+ days ago
Job type
- Full-time
Job descriptionAbility 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 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 A minimum of 3 years of supervisory experience or equivalent
Quality Control Supervisor
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 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 effective product is distributed to customers. Responsible for approval or rejection of components, finished 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
Education & Experience
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Quality Control Supervisor • Conshohocken, PA, US