Job Description

**Summary of Position: 

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Reporting to quality leadership, 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:¨NBSP;

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• Demonstrate team leadership, train, and provide guidance to Quality Control personnel.

• Aligns and prioritizes workload. Creates targets and expectations for work performance.

• Coaches and corrects team as required.

• Provides input for performance appraisals to employees.

• Train and perform inspections on machined components and assemblies using visual and layout techniques and equipment, such as microscopes, calipers, micrometers, and gages.

• Create, complete, and compile documentation related to Quality Inspection standards, ensuring proper material control, identification, and traceability throughout the manufacturing processes.

• Ensure conformance to Quality standards by reviewing Device History Records (DHRs) and ensuring they align with the Device Master Record (DMR), and that Good Document Practices (GDP) are maintained for Routers, Inspection Plans, and DHRs during the manufacturing process and final lot release.

• Utilize ERP and QMS systems to document inspection activities, ensure traceability, and maintain proper control of records.

• Support continuous improvement efforts aligned with Quality Best Practices and GDP/GMP standards.

• Execute Incoming, In-process, and Final Inspections as assigned, recording nonconformities, ensuring follow-up actions, and moving materials into MRB if issues remain unaddressed.

• Perform material sorts as needed, ensuring nonconformities are identified and addressed.

• Follow safety and health requirements, including Personal Protective Equipment (PPE) guidance and rules, throughout all tasks.

• Adapt to different quality standards, production lines, and teams, and move between multiple departments and production lines as required with a proactive approach.

• Support other Quality Department functions as needed, ensuring flexibility in role responsibilities.

• Support physical and electronic record retention processes as needed.

• Ability to use more complex measurement equipment (Comparator, Vision System, Basic CMM operation)

• Performs process audits to ensure that processes are being performed in accordance with procedures and standard work.

• Trains others to clarify standards and requirements.

• Train and perform further complex inspections on machined components utilizing methods such as comparators, CMM, vision systems, contracers and automated techniques.

• Provide basic programming assistance for complex inspection and test methods, as required.

• Execute First Piece, FAI Inspection, as assigned.

• Supervises and trains others on sorting activities and inspections.

• Evaluates compliance process controls (i.e. SPC, Precontrol, Tool Life, Process Parameter) and train others on process standards.

• Adhere to the TOMZ Quality Management System.

• Perform other duties as assigned.

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**Qualifications:

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• 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.

• Ability to work both independently and as part of a team.

• Verbal and written English language communication skills.

• Basic mathematical computational ability

• 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.

• Class I, II and/or III Medical Device manufacturing experience.

• Regulated manufacturing industry experience (e.g., Aerospace, Defense, Pharmaceutical, etc.)

**Education:

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

**Experience:

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• Minimum of 5 years’ experience in a regulated manufacturing environment or equivalent education and experience.

**Preferred Skills:

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• Quality certification(s) (e.g., ASQ CQT, QCI, etc.).

• Knowledge of and experience with GMP/ISO standards.

**Physical Demands:

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• Ability to bend, stoop, squat, kneel, and lift up to 50 pounds. Team lift or mechanical assistance required for objects over 50 pounds.

• 20/20 vision (assisted or unassisted) required for sorting raw and non-conforming materials. Good dexterity is needed for managing small to medium products.

• Exposure to oil, grease, occupational noise, cleaning solvents, dust, metal particles, sparks, coolant, and sharp-edged materials. Personal protective equipment (PPE) such as safety glasses, dust masks, ear plugs, cut-resistant or chemical-resistant gloves, and engineering controls may be required.

• Ability to sit or stand for prolonged periods

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• Perform keyboard entries with possible frequent operation of a computer.

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