ISO-9001

2015 compliant environment: The Mechanical Engineer / Quality Specialist will report directly to the Plant Manager with dotted line reporting to the company president. An elevated level of independent activity is expected. This position is on-site. Key Responsibilities The employee is required to perform all or a combination of the following essential responsibilities as determined by business objectives Manufacturing support: Support manufacturing processes, including failure analysis, documentation review and approval, equipment qualification/calibration, and defect containments. Ensure manufacturing activities follow QMS. Support development and execution of process validation and verification test plans, protocols, and reports. Perform and coordinate PPAP inspections and product verification activities. Ensure compliance with drawings, specifications, and customer requirements. Administer and improve quality processes, with a focus on Lean process management. Assist manufacturing and product development with documentation, guidance, and execution of design verification/validation and process validation. Lead implementation and improvement of manufacturing-related quality processes.

Continuous Improvement:

Lead and manage initiatives in multiple product and process quality areas. Ensure successful, on-time completion of continuous improvement and capex projects. Support internal and external audits, prepare and review back-room documentation. Full responsibility of change order and deviation processes. Lead timely investigation (root cause analysis), disposition (including corrective and preventative actions), tracking, and reporting of non-conformances (NCP), both internal and supplier related. Track KPIs including delivery performance, NCPs, cost of quality, and customer satisfaction. Ensure QMS integrity during changes and process improvements. Maintain technical documentation in support of QMS Quality Management System (QMS) Maintain and improve the

ISO 9001

2015 Quality Management System. Control and update the Quality Manual, procedures, and work instructions. Maintain and administer IQM (Ideagen Quality Management) system including document control, audits, assets, and workflow processes Perform, Coordinate and Support internal and external (including customer) audits. Identify risks and opportunities and support QMS planning and improvements. Ensure controlled implementation of QMS changes and improvements in compliance with ISO standards. The employee may be required to perform other non-essential functions, follow any other job-related instructions, and perform any other job-related duties requested by their supervisor. Key Requirements

EDUCATION

- associate's degree in industrial engineering (IE), manufacturing engineering technology (MET), or equivalent (bachelor's degree preferred). SKILLS - Pragmatic, entrepreneurial personality, and strong initiative-taker. Continually strives to improve.

EXPERIENCE - A

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