OPK Machining Team 1 - Quality Inspector/Technician

About the role

This role involves performing first piece, in process and final inspection or test on a wide variety of parts, documenting results, communicating discrepancies, maintaining product traceability, and participating in internal audits.

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
• 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
• Auxiliary with distribution and control of process documentation and quality records
• Auxiliary 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
• 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

Requirements

• 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
• 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

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
• 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

Skills

• Proficient in the use of measuring and test equipment
• 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

Benefits

• Medical, dental, and vision benefits-effective on date of hire
• Generous paid time off benefits and 10 paid Holidays
• 3 weeks plus 2 days of PTOPaid lunch time
• Company-paid life insurance
• 401k plan with company match

Career Growth

• Tuition Reimbursement
• On-site Training Programs
• Defined Career Path for advancement in role and compensation
• New Hire On-boarding Training Plans

Our Work Environment

• Climate Controlled in the summer months
• Clean & Comfortable Setting
• Schedule hours: 1st shift Mon.-Fri. 7am-3pm

Environmental Working Conditions

• Employee must comply with all safety policies and safe work procedures established by the company

Physical Demands

• Lifting up to 50 pounds
• Frequent carrying, bending, standing, sitting, and repetitive motion