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