Quality Control Supervisor
1 week ago
IntePros is currently looking for a Quality Control Supervisor to join one of our growing medical device clients in Conshohocken, PA. 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.
Quality Control Supervisor Responsibilities:
- 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
- Oversee 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
- 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
- Maintain acceptable attendance and punctuality for scheduled work hours and meetings
- Ensure completion of assigned tasks and responsibilities within defined timeframes
- Flexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice to support business/operational needs when necessary
- Perform other duties as assigned
- 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
- 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
- Clearance of favorable background investigation required
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