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    Quality Inspector II - Berlin, United States - TOMZ Corporation

    TOMZ Corporation
    TOMZ Corporation Berlin, United States

    3 weeks ago

    Default job background
    Upper Management / Consulting
    Description

    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.
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