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Quality Control Manager

Job Summary

Manages the inspection and testing of materials, parts, and products to ensure adherence to established quality standards. Proposes corrective actions to improve compliance with quality specifications. Recommends new or improved quality control methods, procedures, and/or standards. Responsible for all areas of Quality Control and working directly with the engineering, tooling and manufacturing functions making sure adequate systems and inspection methods and tools are used throughout the plants. Understanding customer requirements and implementing action plans, purchasing equipment or tools necessary to perform tasks. Ensure proper controls, operator instructions and quality tools used to verify customer’s products at all phases within our process.

Essential Job Function

· Review daily rejects or complaints and implement or discuss action plans

· Disposition In-Process rejected product from previous day (MRB), if required.

· Make appropriate changes in documentation to prevent recurrence.

· Make appropriate changes to fixtures or inspection methods and tools.

· Create/Modify and Maintain History Cards/ Control Plans.

· Make decisions regarding quality related questions as appropriate.

· Contact customers via verbal/written communication as appropriate.

· Create/Maintain FMEA’s, Control Plans, Validation Plans, IQ/OQ/PQ protocol’s, PPAP’s as appropriate.

· Participate in design reviews as required.

· Visit customers with regards to customer complaint resolutions.

· Participate in plant/department meetings and tours as required.

· Review PPAP, Validation Data, and M&P studies before sending to customer.

· Work with Engineering, MFG and Tooling to develop corrective actions and continuous improvement activities.

· Report any unsafe conditions to Manager or Safety committee member

· Maintain cleanliness of work areas and quality measuring equipment

· Additional responsibilities may be assigned as needed.

Minimum Requirements

· Bachelor's degree from a four-year college or university preferably in a life science discipline or equivalent experience.

· Quality position in a Life Science business, managing product or service in a regulated QMS. At least 5 years of experience in an ISO (preferably 9001) and/or FDA regulated environment, with at least 5 years of direct quality relevant experience.

· Experience with ISO 9001 certification required.

· Experience in a Good Manufacturing Practice (GMP) environment.

· Ability to make and implement policy and procedure effectively through timely training.

· Strong ability to write clear, concise communication to customers and suppliers.

· Ability to collaborate with site leadership team to create consensus on initiatives.

· Superior team building and leadership skills.