A Quality Engineering Manager interfaces with customers, suppliers, and various company departments to resolve quality problems and develop strategic quality improvement activities. Responsible for building strong relationships with the global customer quality organizations to ensure customer support and product performance through continuous improvement.
Manage, implement, and continuously develop the company's Quality Management System (QMS) in compliance with medical device industry requirements. Ensure compliance with FDA Quality System Regulation (QSR), ISO 9001, ISO 13485, and
ISO 14971
standards and requirements. Oversee quality system activities including CAPA, complaint handling, document control, change control, and design control. Manage internal and external audits, including preparation, execution, findings, corrective actions, and follow-up activities. Provide quality support for supplier development, supplier controls, process development, and process validation activities. Develop and maintain control plans and quality procedures to ensure consistent product and process compliance. Apply knowledge of Good Laboratory Practices (GLP), sterilization equipment, sterilization methods, and related procedures. Provide technical and statistical support to Quality Control teams, including data analysis, process monitoring, and problem resolution. Support continuous improvement initiatives focused on quality, efficiency, compliance, and overall operational performance. Lead and manage quality personnel, including workload planning, performance management, technical mentoring, and development of team members.
Education:
A minimum of a Bachelor's degree in Engineering or a relevant scientific discipline with a focus 7 years of relevant experience, or a Master's degree in the same with 5 years of experience is required. Appropriate certifications may include Certified Quality Engineer, Certified Quality Auditor, and Certified Lead Auditor. Six Sigma Green Belt is desirable. Training in Lean and 5S are desirable.
Experience:
Minimum of 5 years' experience in the medical device field in roles such as quality engineer, quality control supervisor, auditor, quality assurance, quality manager. Familiarity with machining, metal finishing, sheet metal fabrication and assembly processes. Familiarity with the orthopedic industry.
A bit about us:
- My client is a leading medical device manufacturer and they are growing! They are looking to add a Quality Manager to their team who manage and monitor performance of all aspects of quality assurance and quality control. The ideal candidate will demonstrate a firm understanding of quality management systems specifically focused in the medical device field. Expert understanding of the
QSR, ISO 9001, ISO
13485, control plans, and
ISO 14971
are required. Why join us? - Compensation Up To $130,000 #manufacturing #medical-device #quality-assurance #iso13485 #process-improvement #continuous-improvement #lean-manufacturing #product-quality #quality-management #quality-management-systems #quality-auditing #corrective-and-preventive-actions-capa #tier1
