Quality Engineering Manager

3 weeks ago


Berlin, United States TOMZ Corporation 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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