Quality Inspector III

TOMZ Corporation; Berlin (CT); On-site; USD 40,000 - 100,000; Full time

Job summary

TOMZ Corporation is seeking a Quality Control Inspector to oversee quality assurance functions in Berlin, CT. The successful candidate will ensure compliance with ISO standards through detailed inspections and documentation. A proven background in regulated manufacturing, combined with strong communication skills, is essential for this role. Join a leading company dedicated to excellence in medical device manufacturing.

Benefits

Medical Insurance

Vision Insurance

401(k)

Qualifications

• 5-7 years of experience in a regulated manufacturing environment is required.
• Knowledge of GMP/ISO standards and quality inspection.
• Quality certification(s) such as ASQ CQT or QCI is preferred.

Responsibilities

• Perform inspections using equipment like microscopes, calipers, and CMM.
• Train and guide Quality Control personnel.
• Maintain ISO 13485 standards documentation.

Skills

Attention to Detail

Mechanical Measurement

Inspection Techniques

Communication Skills

Education

High school diploma or GED

Tools

Micrometers

Calipers

CMM

Visual Inspection Equipment

Job description

1 day ago Be among the first 25 applicants

Direct message the job poster from TOMZ Corporation

Consider joining our team in Berlin, CT!! Reporting to the Quality Manager, this position will have direct responsibility for the quality control functions within the Department. TOMZ manufactures parts via high precision metal machining, assembly, and anodize processes for Medical Devices. The successful candidate will be expected to maintain the ISO 13485 standards documentation and perform inspections on machined components by utilizing conventional layout inspection techniques and equipment.

Essential Functions:

• Train and perform inspections on machined components, utilizing conventional visual and layout inspection techniques and equipment. Ex. include microscopes, calipers, micrometers, and gages.
• Train and perform further complex inspections on machined components utilizing methods such as comparators, CMM, various manual and automated techniques.
• Demonstrate team leadership, train, and provide guidance to Quality Control personnel.
• Execute Incoming, First Piece, FAI, In-process, and Final Inspection, as assigned.
• Creates, completes, and compiles necessary documentation related to Quality Inspection standards.
• Provide basic programming assistance for complex inspection and test methods, as required.
• Ensure proper material control, identification and traceability is maintained for conforming and nonconforming material through the manufacturing processes.
• Ensure and enforce a thorough review and adherence to Good Document Practices (GDP) for Routers, Inspection plans, and Device History Records (DHRs) throughout the manufacturing process and in preparation for the final lot release and shipment.
• Support Quality Best Practices and GDP/GMP continuous improvement efforts.
• Utilize and navigate ERP and QMS systems to ensure inspection and traceability activities are properly documented and controlled, as needed.
• Utilize the ERP system to prioritize and support product final acceptance and shipment, as needed.
• Generate Packing Slips and Certificates of Compliance (C of C) in accordance with TOMZ and customer requirements.
• Support physical and electronic record retention.
• Must follow occupational Safety and Health requirements including Personal Protective Equipment (PPE) guidance and rules.
• Adhere to the TOMZ Quality Management System.
• Perform other duties as assigned.

Qualifications:

• Quality certification(s) (e.g., ASQ CQT, QCI, etc.).
• Class I, II and/or III Medical Device manufacturing experience.
• Regulated manufacturing industry experience (e.g., Aerospace, Defense, Pharmaceutical, etc.)
• Knowledge of and experience with GMP/ISO standards.
• 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.
• The ability to effectively read and understand blueprints, specifications and procedures.
• Maintains accuracy and attention to detail at all times and completes tasks in a timely manner.
• Knowledge of dimensional, visual, and mechanical inspection processes.
• Competency with Microsoft Office.
• “Hands-on” self-starter with ability to work both independently and as part of a team.
• Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA, as required, accomplishing results with minimal guidance.
• Strong verbal and written English language communication skills.

Education:

• High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).

Experience:

• Minimum of 5-7 years’ experience in a regulated manufacturing environment.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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