TOMZ Corporation is looking for a Quality Systems Specialist to join our organization. A leader in manufacturing of devices and components for major medical device companies, TOMZ offers competitive compensation and excellent benefits. Those include 401k, health/dental, vision and paid time off. TOMZ maintains modern, clean, and safe facilities 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:
The position will be responsible for ensuring global operational adherence and compliance to TOMZ's Quality Management System (QMS) requirements. This role will be expected to provide input on, and contribute to, development and implementation of Quality System improvement strategies and approaches.
ESSENTIAL FUNCTIONS:
Lead Quality Management System initiatives and continuous improvement activities.
Generate project Quality Plans for the QMS and Organizational Objectives.
Facilitate organizational compliance training and continual audit/assessment preparedness.
Actively support site customer-requested auditing activities (Customer and Regulatory Agencies).
Coordinate tracking/trending & reporting of quality system metrics and inputs to Management Review(s).
Internal Auditing.
Additional responsibilities as outlined in full job description.
QUALIFICATIONS:
Education
Minimum 4-Year degree or equivalent of directly transferrable industry work experience (Engineering or Quality discipline preferred).
Experience
Minimum of 4-6 years' experience in a regulated manufacturing environment.
***Additional qualifications as outlined in full job description.