Quality Systems Specialist

The Quality Systems Specialist will assist with planning, implementing, and sustaining a site-wide quality management program.

Essential Functions

• Quality Management System Support: Assist in the definition, implementation, and maintenance of quality processes and procedures supporting business and regulatory needs.

• Support Corrective and Preventative Action Program (CAPA) – Identify problems, establish effective corrective actions, and work with others to resolve problems.

• Document Control – Assist with management of document control processes.

• Assist with administering and expanding site training program, including collection and organization of training records.

• Coordinate completion of annual calibration activities.

• Assist with regulatory technical file maintenance: RoHS Certificates, REACH, etc.

• Participate in the investigation of customer complaints. Review and approve complaint records.

• Test and inspect product at specified stages in the manufacturing process to ensure compliance with specifications.

• Support incoming quality inspection program (non-conformance disposition, return of material to suppliers, tracking supplier performance).

• Provide guidance to document authors to ensure accuracy, correctness and consistency.

• Lead internal audits of quality processes such as Document Control, Training, CAPA, Deviation, etc. to ensure site procedures are followed.

• Support internal and external audits.

• Assist with generating monthly metrics for divisional and corporate leadership.

Required Skills & Abilities:

• Detail-oriented and a creative problem-solver.

• Strong relationship building skills.

• Excellent written and oral communication skills.

• Ability to learn specialized databases and software systems

• Ability to work independently, with minimal supervision

• Strong Microsoft Office computer skills, and experience working with data analysis and problem solving tools.

• Excellent analytical skills. Able to use data to identify trends and understand problems.

Preferred Skills & Abilities:

• Working knowledge of ISO 9001 and/or ISO 13485 requirements

• Experience working in an electronic manufacturing environment

• Bill of Material (BOM) maintenance and review experience

• Experience participating as part of an audit team