Essential Functions:

· Perform quality audits of finished goods, packaging materials, work-in-process and returned goods. Audit compliance to customer requirements for assembly, documentation and control of manufacturing in the facility.

Duties/Responsibilities:

· Audit production lines according to established procedures and properly documents results. This includes reviewing documentation on the production lines for conformance to customer standards and Good Manufacturing Practices (GMPs).

· Conduct QC tests as required using statistical sampling procedures and document properly.

· Collect and maintain retain samples of all products manufactured. Collect customer samples and submits them to the customer according to established procedures.

· Inform the QA Manager and Operations of any variations from standards in a timely manner. Resolve quality issues with Operations and the customer as necessary.

· Inspect returned goods according to established procedure and disposition the material based on the inspection. Maintain accurate records of return goods and packaging.

· Monitor GMP compliance while on production lines. Report all non-compliance and complete documentation.

· Maintain accurate records.

· Re-inspect and disposition substandard product rework. Document results properly.

· Develop strong working relationships with cross functional departments and employees.

· Monitor quality data and record trends.

· Assist in investigations, deviations, corrective actions and continuous improvement.

· Ensure line equipment is calibrated. Routinely check calibration dates and report missing calibration stickers.

· Maintain a strong commitment to quality at all times.

· Responsible and accountable for Good Manufacturing Practices (GMPs), and standard operating procedures (SOPs).

· Keep work area neat and orderly.

· Follow all company rules.

· Perform all duties in a safe manner using proper tools and wearing appropriate protective equipment as required.

· Perform other duties as assigned.

Education/Training Required:

· High School Diploma or GED equivalent required.

· At least 1 year experience in similar role in a manufacturing environment.

· Must be proficient in math.

· Must have good verbal and written communication skills and be able to follow both verbal and written instruction.

· Must have good leadership skills for directing, instructing and training team members.

Physical Demands:

· May occasionally lift up to 25 lbs.