Description
Position SummaryPlan, direct and monitor Quality Assurance (QA) activities to ensure that components and finished products are processed in accordance with internal and external policies and procedures. Work as part of the plant management team to achieve plant and company goals/objectives. Ensure the plant operates in a state of compliance and maintains the effectiveness of the Quality Management System with internal policies and procedures as well as domestic and international regulations and standards (e.g. FDA, ISO, MDD) for combination products. Ensures the quality policy is communicated and understood within the plant.
Provide quality leadership and technical support for plant and company product, process, and design improvement projects. Lead and direct quality system improvement programs in the plant. Has direct responsibility and accountability for all aspect of Manufacturing Quality, Supplier Quality, Lot Release, Receiving Inspection and Document Control. Applies knowledge of quality engineering techniques to ensure they are continually manufactured in accordance with internal, regulatory and customer requirements.
Principal Accountabilities
- Establish and implement a Quality Management System that complies with domestic and international quality system requirements and guidelines for combination products and in accordance with the Final Rule.
- Has overall responsibility and management for Manufacturing Quality Engineers, Supplier Quality Engineers, Receiving Inspection, Analytical Lab and Document Control teams; including hiring, training, motivating, monitoring, evaluating, and directing.
- Monitors, evaluates and improves overall effectiveness of product performance through strategic and tactical planning and execution with Senior Management in Operations, Clinical, R&D, Regulatory Affairs and Marketing.
- Provides guidance to Manufacturing Quality and Supplier Quality Engineering staff and other personnel to ensure that appropriate quality monitoring and controls are in place and continually being improved.
- Provides leadership and guidance in developing manufacturing documents including inspection procedures and manufacturing procedures along with appropriate operator training to ensure that the resulting products can be appropriately manufactured, tested, and released.
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