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
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
- Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
- 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 are assigned.
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.
Physical Demands
While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 20 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.