Minimum of 8 years’ experience in a combination of manufacturing, auditing, corrective action and supplier/customer interface. Formal lead auditor training required with ISO 9001 minimum; AS9100 and/or ISO 13485 preferred.
Coordinate and maintain the internal quality audit program and ensure compliance to customer and 3rd party certification requirements
- Act as Management representative for ISO 9001/AS9100 and ISO 13485 QMS
- Proficient with supplier, internal and customer audits.
- Schedule/perform internal audits and coordinate with area supervisors to maintain schedules.
- Maintain computerized databases and filing systems in conformance with documented procedures.
- Understand and follow SOP, Slashes, PDC, SDS and other applicable specifications.
- Develop or assist in developing and revising Standard Operating Procedures, Control Plans, FMEAs, PDCs and Slash Sheets to implement customer/supplier requirements.
- Coordinate, perform and maintain supplier audit and corrective action programs.
- Administer internal and supplier corrective action programs.
- Follow up on the effectiveness of corrective/preventive actions.
- Provide support for supplier development programs and quarterly supplier score card
- Adhere continuously to good housekeeping standards.
- Meet or exceed output goals and perform other duties as assigned
- Stand, walk, bend, lift etc., as required.
- Adhere consistently to safety practices.
- Work overtime as needed.
- Train personnel as required.