Quality Engineering Manager

3 weeks ago


New York, United States Tomz Full time

TOMZ Corporation is looking for a Quality Engineering Manager to join our organization. A leader in manufacturing of devices and components for major medical device companies, TOMZ offers competitive compensation and excellent benefits, including 401k, health/dental, vision and paid time off. TOMZ maintains a modern, clean, and safe facility with state-of-the-art equipment and dedication to continuous process improvement. TOMZ is registered with the FDA as a Class 2 and Class 3 Medical Device Manufacturer and is certified to ISO 13485.

SUMMARY OF POSITION: This position will be responsible for the Leadership and management of site-level Quality Engineering personnel and resources to ensure adherence and compliance to TOMZ's Quality Management System.

ESSENTIAL FUNCTIONS: This position may have direct-reporting responsibilities for daily activities of Quality personnel. Designated Site-level Management Representative for assurance of compliance to the TOMZ Quality Management System. Drive and support QMS initiatives and continuous improvement activities. Support establishment and maintenance of site regulatory registrations (ISO 13485, FDA, etc.). Provide organizational Quality Leadership, coaching, mentoring and guidance to all Quality Engineering, as well as cross-functional teams. Work closely with Engineering and Operations teams to identify and drive actions that reduce the Cost of Poor Quality. Drive integration of new manufacturing capabilities, new test methods and innovation in technology, cost/labor reduction opportunities, product transfers, design transfers and sustained manufacturing customers. Additional responsibilities as outlined in the full job description.

QUALIFICATIONS: Education Minimum 4-Year degree or equivalent of directly transferrable industry work experience (Engineering or Quality discipline preferred).

Experience of 1-3 years Leadership/Supervisory-level experience, with budget and decision-making authority/responsibilities. of 5 years of experience in a regulated manufacturing environment.

*** Additional qualifications as outlined in full job description.



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