Join our team in Big Lake! We are hiring a Quality Cell Lead!

Summary of Position:

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 passivation/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. This role also serves as the point of contact for quality issues on the production floor and leads efforts to drive continuous improvement projects.

Essential Functions:

• Performs inspections on machined components and assemblies, utilizing conventional visual and layout inspection techniques and equipment. Ex. include microscopes, calipers, micrometers, and gages.

• Creates, 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.

• Supports physical and electronic record retention and accurately reviews and ensure the Device History Records (DHRs) have been executed in accordance with the Device Master Record (DMR i.e. correct process and revision) and that 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.

• Utilize the ERP system to prioritize and support product final acceptance and shipment, as needed.

• 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.

• Is capable of inspecting **90%**of products with expected proficiency without supervision or outside support.

• Execute Incoming, and Final Inspection, as assigned.

• Utilize and navigate ERP and QMS systems to ensure inspection and traceability activities are properly documented and controlled, as needed.

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

• Record nonconformities found in process, follow up to ensure any nonconformities were addressed, and move material into MRB if the issue was not addressed.

• Coordinate containment actions and assist in root cause analysis.

• Support the investigation and implementation of Corrective and Preventive Actions related to cell-level issues.

• Perform material sorts as required.

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

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

• Train and perform 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.

• Coaches and corrects team as required and provides input for performance evaluations of employees.

• Aligns and prioritizes workload.

• Creates targets and expectations for work performance

• Support other Quality Department functions, as needed.

Qualifications:

• 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.)

Preferred Qualifications:

• Quality certification(s) (e.g., ASQ CQT, QCI, etc.).
• Knowledge of and experience with GMP/ISO standards.

Education:

• High school diploma, GED, or equivalent directly transferrable work experience

Experience:

• Minimum of 6 years’ experience in a regulated manufacturing environment or equivalent education and experience.

Physical Requirements:

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