TOMZ Corporation is looking to hire a highly motivated Senior Quality Engineer – Sustained Manufacturing 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 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 activities associated with Quality Sustained Manufacturing of commercial product and successful transfer of Development programs to standard production, through leadership, coaching and technical guidance of cross-functional Engineering teams. This role will be expected to provide input on, and contribute to, development and implementation of Quality System improvement strategies and approaches. Fast-paced work environment.
ESSENTIAL FUNCTIONS:
- Initiate and/or consult in the development and/or update of Risk Management FMEA documentation in cooperation with cross-functional engineering teams per project requirements.
- Support operational and process qualifications for customer manufacturing processes in cooperation with cross-functional engineering teams.
- Provide direction in implementing and continuously improving Incoming Inspection, First Article Inspection, In-Process and Final Product Inspection plans.
- Ensure the continuous efficiency and improvement of Test/Inspection Methods
- Develop and justify appropriate sampling plans with characterization of test/inspection methods and acceptance criteria.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, including CAPAs, Complaints and NCRs.
- Other responsibilities required 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 7+ years’ experience in a regulated manufacturing environment.
