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Quality Inspector II

4 months ago

Berlin, United States TOMZ Corporation Full time

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.