OPK Machining Team 1 - Quality Inspector/Technician

OPK Machining Team 1 - Quality Inspector/Technician Perform first piece, in process and final inspection or test on a wide variety of parts and document results. Indicate inspection status; maintain product traceability and non-conforming material control. Participate in internal audits, statistical process control and assist control of process documentation, records and equipment calibration. Essential duties and responsibilities: Perform required inspections, measurements and testing of incoming parts, production first piece, in-process and finished product per established criteria Record results on appropriate documentation. Communicate any discrepancies to the person(s) responsible for corrective/preventive action activity Perform various dimensional inspections using specific dies, gages, microscopes, micrometers and other dimensional inspection system Indicate inspection status of parts with assigned labels and stamps Maintain product identification and traceability Control non-conforming product in accordance with documented procedures and verify timely corrective and preventative action Protect product during handling and storage in the performance of work Monitor factory environmental conditions, record data and identify adverse conditions Assist with distribution and control of process documentation and quality records Assist with control of measuring and test equipment calibration Participate in internal quality audits to verify compliance with documented procedures and specifications, record results and verify audit corrective action Assist with statistical methods of verifying and controlling process capability Provide leadership to production personnel on quality issues Comply with and reinforce the requirements of the Quality Manual and Standard Operating Procedures, ISO 13485, FDA Quality System Regulations and other customer standards Follow Occupational Safety and Health regulations, including laser safety practices. Performs job duties with little or no supervision or assistance Environmental working conditions: Using personal protective equipment such as safety glasses, goggles, gloves, and other equipment as established in company policies and safe work procedures Working near cutting & machining fluids, solvents, lubricants and other hazardous chemicals using appropriate safety controls Lifting up to 50 pounds Frequent carrying, bending, standing, sitting, and repetitive motion Qualifications: Minimum 2 years' experience as an inspector or 4 years manufacturing experience as a machine operator in a manufacturing or production environment. Prior medical device, aerospace, automotive or regulated Manufacturing environment preferred Certificate(s) of training related to this field of work (medical device industry or quality assurance) preferred Prior experience interpreting technical drawings & specifications required Proficient in the use of measuring and test equipment Demonstrate ability to check dimensions, surface relationships, finish material defects and mechanical strength of product following appropriate training Prior experience in the use of PC's and Microsoft Office software applications required It is impossible to list every requirement for, or responsibility of, any position. Similarly, we cannot identify all the skills a position may require since job responsibilities and the Company's needs may change over time. Therefore, the above job description is not comprehensive or exhaustive. The Company reserves the right to adjust, add to, or eliminate any aspect of the above description. The Company also retains the right to require all employees to undertake additional or different job responsibilities when necessary to meet business needs.

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