Quality Inspector II

TOMZ Corporation; Big Lake (MN); On-site; USD 52,000 - 66,000; Full time

Job summary

TOMZ Corporation in Minnesota seeks a Quality Control Inspector to oversee inspection activities within the department for medical device manufacturing. The role emphasizes adherence to ISO 13485, GDP/GMP, and proper documentation of inspections on machined components using conventional layout techniques and equipment.

Responsibilities include performing complex inspections with CMM and gauges, ensuring material traceability, maintaining accurate records in ERP/QMS, and generating COCs and

Qualifications

• 3–5 years of experience in a regulated manufacturing environment.
• Reading blueprints and procedures; using gauges and metrology equipment.
• Knowledge of GDP/GMP and ISO 13485 standards.

Responsibilities

• Perform complex inspections on machined components using CMMs and gauges.
• Provide training for inspections on machined components using visual/layout techniques.
• Execute Incoming, First Piece, FAI, In-process, and Final inspections.
• Compile and maintain documentation related to Quality Inspection standards.
• Ensure material control, identification and traceability is maintained.
• Review GDP compliance for DHRs, routers and device history records.
• Support ERP and QMS documentation activities; assist in final acceptance and shipments.
• Generate Packing Slips and Certificates of Compliance as required.
• Adhere to PPE and safety rules; support record retention.

Skills

Blueprint reading

Dimensional measurement

Quality documentation

Attention to detail

Teamwork

English communication

Education

High school diploma or GED

Job description

Summary Of Position

Reporting to Department 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/or perform inspections on machined components by utilizing conventional layout inspection techniques and equipment.

Summary Of Position

Reporting to Department 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/or perform inspections on machined components by utilizing conventional layout inspection techniques and equipment.

Essential Functions

• Perform further complex inspections on machined components utilizing methods such as comparators, CMM and/or various manual and automated techniques.
• Perform and provide training assistance for inspections on machined components, as required, utilizing conventional visual and layout inspection techniques and equipment. Ex. include microscopes, calipers, micrometers and gages.
• Execute Incoming, First Piece, FAI, In-process, and Final Inspection, as assigned.
• Completes and compiles necessary documentation related to Quality Inspection standards.
• Ensure proper material control, identification and traceability is maintained for conforming and nonconforming material through the manufacturing processes.
• Accurately review and ensure Good Document Practices (GDP) are upheld for Routers/Inspection Plans/Device History Records (DHRs) throughout the manufacturing process and in preparation for final lot release/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/or customer requirements.
• Support physical and/or electronic record retention.
• Must follow occupational Safety and Health requirements including Personal Protective Equipment (PPE) guidance and rules.
• Other duties and responsibilities as assigned.

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.