Quality Inspector II

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.