OPK Machining Team 1 - Quality Inspector/Technician

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 include:

• 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 include:

• 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