Quality Control Supervisor

Responsibilities include providing quality guidance, product resolution decisions, and statistical problem-solving techniques to manufacturing operations and project teams for new product introduction, process improvements, continuous improvements, and validation activities. Responsible for the quality of the product and process for the assigned product line(s). Will directly supervise quality control associates across all production crews.

• Coordinates product team support for receiving inspection, manufacturing operations and the release of product (including, customer complaints, help desk responses, statistical analysis, validation support, inspection plans, quality metrics and reporting functions.)
• Support the investigation of Corrective & Preventive Actions (CAPA), product non-conformances, and of customer complaints, providing solutions where possible; support Continuous Improvement activities.
• Develop and implement incoming inspection plans for raw materials.
• Develop/Revise Quality Plans including incoming, in-process, and final inspection; provide training to those affected by the plans.
• Implement proven inspection and metrology improvements and associated training.
• Create / Revise technical process documents that fit the business needs and maintain compliance to the regulatory requirements of the FDA and ISO standards.
• Serve as a resource for performing internal audits to ensure quality system compliance.
• Process incoming customer complaints assist with complaint investigations and provide documented feedback of corrective actions to the customers; provide customer support through help desk ticket responses, including completion of requested technical questionnaires, and providing evidence of quality/ regulatory certification for the plant.

• Bachelor’s Degree in technical field (Engineering or Statistics preferred.)
• 3+ years of Quality Control experience with corresponding leadership or supervisory responsibilities.
• Familiar with regulatory industry requirements such as ISO13485, ISO 15378, Quality Systems Regulation CFR 21 part 820, GDP / GMP-Good Doc / Good Manufacturing Practices.