Job Details
TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a Quality Inspector to join our organization. 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:
The successful candidate will be expected to perform inspections on machined components by utilizing conventional layout inspection techniques and equipment.
Technical Skills:
- Inspection Techniques: Proficiency in using various inspection methods like comparators, CMMs, microscopes, calipers, micrometers, and gauges.
- Documentation: Ability to accurately complete and compile quality inspection documents according to established standards.
- Material Control: Understanding of proper material identification and traceability throughout manufacturing processes.
- Document Review: Familiarity with reviewing and ensuring Good Document Practices (GDP) for Routers, Inspection Plans, and Device History Records (DHRs).
- Quality Systems: Experience using ERP and QMS systems for documenting and controlling inspection and traceability activities.
- Packaging & Documentation: Knowledge of generating Packing Slips and Certificates of Compliance (C of C) according to requirements.
- Records Management: Familiarity with physical and electronic record retention procedures.
Other Skills:
- Attention to Detail: Demonstrated ability to work meticulously and accurately.
- Problem-Solving: Skill in identifying and resolving quality issues with machined components.
- Communication: Effective communication skills to interact with colleagues, supervisors, and customers.
- Safety: Commitment to following occupational safety and health requirements, including PPE use.
Additional Notes:
- The specific requirements of the role may vary depending on the company and industry.
- Familiarity with the relevant regulations and standards for the industry is a plus.
- Candidates with experience in the manufacturing environment will be at an advantage.
QUALIFICATIONS:
Education
- High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).
Experience
- Minimum of 3-5 years experience in a regulated manufacturing environment.
Qualifications
- Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
- Ability to effectively read and understand blueprints, specifications and procedures.
- Knowledge of dimensional, visual and mechanical inspection processes.
- Strong background concerning the usage and care of mechanical measurement equipment, tools and hand-held tools including micrometers, calipers, dial indicators, height gages, pin gages, etc.
- Maintains accuracy and attention to detail at all times and completes tasks in a timely manner.
- Hands-on self-starter with ability to work both independently and as part of a team.
- Strong verbal and written English language communication skills.
- Competency with Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint).
- Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA, as required, accomplishing results with minimal guidance.
Preferred Skills
- Quality certification(s) (e.g. ASQ CQT, QCI, etc.).
- Class I, II and/or III Medical Device manufacturing experience.
- Knowledge of and experience with GMP/ISO standards.