 Lead/Participate in FDA and Notified Body inspections.  Manage and supervise the day-to-day activities of receiving, in-process, final inspection and DHR review functions. Coordinate and manage work schedules of employees to maintain production goals. Initiate cost of quality improvement programs.  Plan, coordinate and direct quality programs, initiatives and activities to ensure the quality and reliability of products. Lead new hire on-board training program to ensure training effectiveness of all employees.  Partner with Regulatory to ensure compliance to all applicable regulations and standards.  Review and approve documents related to validation activities, including protocols, reports, deviations, change controls, trend report, procedures, policies, and annual product reviews. Write new programs, evaluate and revise current programs for engineering changes or to increase operating efficiencies.  Perform complex geometric dimensional inspections on first piece, in-process and finished products ensuring compliance to customer specifications. Take specified samples of various sizes of mechanical seal, machined, molded or stamped component parts which contain varied and sophisticated surface relationships and high finish quality of stainless steel, aluminum, carbide, rubber and special items Interpret detailed blue prints, work orders, engineering specifications and routing sheets to determine production standards and tolerance limits. Conduct investigations on internal and external NCR’s.  Initiate Supplier Corrective Action requests, participate in any supplier audit when requested.  Initiate, investigate, close and train employees on CAPA program.  Participate in daily Gemba walks to ensure effectiveness of all departments.  Quality Representative on new product development process to ensure all cross functional design/develop requirements are met.  Demonstrates substantial knowledge of industry best practices and trends

 Plan, coordinate and direct quality programs, initiatives and activities to ensure the quality and reliability of Bradshaw Medical products. Operate, program and train associates on Zeiss CMM. Write new programs, evaluate and revise current programs for engineering changes or to increase operating efficiencies  Perform complex geometric dimensional inspections on first piece, in-process and finished products ensuring compliance to customer speficiations. Take specified samples of various sizes of mechanical seal, machined, molded or stamped component parts which contain varied and sophisticated surface relationships and high finish quality of stainless steel, aluminum, carbide, rubber and special items Interpret detailed blue prints, work orders, engineering specifications and routing sheets to determine production standards and tolerance limits. Manage and supervise the day-to-day activities of receiving, in-process and final inspection functions  Coordinate and manage work schedules of employees to maintain production goals. Instruct quality technicians in new or best measurement systems and techniques.  Provide support for released products, and recommend corrective and preventative actions.

 Review and implement customer contractual quality requirements. Direct actions required of other departments to comply. Work with customer quality representatives to perform source inspections, quality systems, product audits and surveys.  Provide training to others in Final Inspection area. Provide assistance to Supplier Quality Engineer and Methods and Manufacturing with inspection requirements and interpretation of Seal Operation specifications. Obtain training from customers to act as Designated Supplier Quality Representative (DSQR).  Coordinate and supervise the day-to-day activities of receiving, in-process and final inspection functions. Prioritize backlog for DRI and customers (internal and external). Schedule source inspection and final releases. Work with complex blueprints, special instructions, sequence sheets, inspection plans, purchase orders, customer orders and codes. Set up specified precision measuring instruments and charting techniques. Inspect component parts and overall product visually for quality characteristics and missing operations with stated measuring instruments for interrelated dimensions of conformance to engineering and customer specifications. Ensure quality and acceptance and release of product for shipment.