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Quality Engineer

Foxx Life Sciences

Londonderry, NH
Global Supplier to the Research, Pharmaceutical & Biotechnology Markets. Foxx sells Tubing, Bags, Bottles, Flasks & Carboy Assemblies, Filtration, Fluid Management & Laboratory Safety Products. Quality Engineer Full Time Londonderry, NH, US Requisition ID: 1133 Apply JOB TITLE: Quality Engineer POSITION REPORTS TO: Quality Manager POSITION SUMMARY: Assist Quality Manager in the maintenance and improvement of the quality management system (QMS) ESSENTIAL JOB FUNCTIONS: • Lead the organizational onsite requirements for the quality management system; • Develop and implement all quality-related processes and documentation for current and new business; • Direct manufacturing process development to meet or exceed the company’s quality metrics and process metrics for current and new business; • Monitor the facility’s overall performance and associated metrics, and create and implement plans to achieve metric targets; • Develop and implement preventative actions and continuous improvements within the manufacturing and quality areas; • Coordinate with the quality inspector for the daily inspection, measurement, test, and approval of all components, product, process and use of quality metrics to ensure quality targets are met; • Communicate and coordinate with management, administrative, operations, quality, and engineering departments; • Review, analyse and resolve customer/internal/supplier quality issues through root cause analysis and implementation of corrective actions with operations; • ISO and customer audits; • Daily use of quality management system software and SPC systems; • Document and record control; • Conduct supplier and internal audits; • Purchase, manage and review gage equipment, certifications and calibrations; • Control the non-conformance area (inventory, disposition, and associated costs.) QUALIFICATIONS: • Medical Product validation experience is essential; • Knowledge and experience of: ISO 9001 and/or ISO 13485 • Process capability and effect on processes, production, equipment, and assembly); • Problem solving methods (5Y, Fishbone, 8D, etc.); • Ability to be self-managed; • Proficient with Microsoflt Office (Outlook, Excel, Word, Powerpoint); • Experience with machining, fabrication, and assembly operations; SUPPLEMENTAL JOB FUNCTIONS: • Performs additional duties as directed.
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