Site Quality ManagerApply Now
Location: Clinton, Massachusetts 01510
Employment Type: Direct Hire
- Responsible for ensuring that all departments/divisions within a plant where
- devices are assembled/packaged with drug/biologic products or diagnostic reagents (Finished Product) comply with applicable regulations and cGMP practices of the US Food and Drug Administration, EU and other global competent authorities.
- Manages all activities and personnel (directly or indirectly) for handling Finished Product from receiving to shipping as well as assessing and ensuring compliance through training, auditing and corrective and preventive actions.
- Serves as the Management Representative for the site, as defined in the following Quality Management System standards & regulations:
- 21 CFR Part 820 Quality System Regulation
- ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes
- Manages the quality unit, executing all functions to fulfill quality assurance requirements to maintain regulatory compliance
- Position reports directly to the Director Quality
- Relocation assistance may be available
Essential Duties & Responsibilities
- Liaisons with external parties on matters relating to the QMS.
- Ensuring that processes needed for the QMS are established, implemented and maintained.
- Responsible for maintaining compliance to 21 CFR Parts 210 and 211 and 21 CFR Part 820 as well as any other relevant global regulations pertaining to the product.
- Participates as a Program Management team member to ensure that Advanced Quality Planning is performed and customer and regulatory requirements are transferred into issued documentation for use in production.
- Ensures that suppliers and contractors are appropriately approved.
- Trains or manages training to ensure that personnel engaged in the receipt, manufacture, processing, packing and holding of Finished Product and their components have the education, training and experience to perform their assigned functions.
- With the support of the plant management and the Healthcare (HC) FinPack team, ensures that the facility and equipment used for manufacture, testing and packaging of Finished Product is of the appropriate design, adequate size and location for the intended use and are cleaned and maintained to prevent contamination and mix-up.
- Ensures that Quality reviews and approves all documents that impact the identity, strength, quality and purity of the Finished Product and that documentation is in compliance with HC GBU, plant, and relevant regulatory requirements.
- Participates in FDA audits and provides input to any 483 responses.
- Assists Quality Engineers, Engineering and Operations staff in developing quality plans, inspection work instructions and procedures, equipment operation documents and any other documents required for batch records.
- Ensures that all plant licenses and registrations are maintained and current.
- Participates in corrective action investigations associated with Finished Product and ensures that true root cause and effective corrective action is enacted.
- Assists in the resolution of FinPack customer complaints with the assistance of assigned quality, operations, and engineering personnel.
- Lead the Quality Assurance Department in operating with a high level of efficiency, integrity and enthusiasm, striving to achieve excellence in all endeavors.
- Provides input to and support of plant and company safety initiatives.
- Co-ordinates interaction between the Quality Department and all other manufacturing and support functions.
Yhoumey is a recruiter for our direct hire team. She enjoys partnering with candidates to find the right career placements.
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