Quality Control Supervisor

Join our growing team in Big Lake, MN! 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 supervise inspectors and packaging personnel while maintaining the ISO 13485 standards, and the requirements of our Quality Manual.

Essential Functions

Demonstrate team leadership, train, and provide guidance to Quality Control personnel. Aligns and prioritizes workload. Creates targets and expectations for work performance. Assist with hiring of new employees (interviews, on-boarding, training) Coaches and corrects team as required, approves time sheets. Drive continuous improvement through the departments with the Quality team.

Identify areas of improvement, and work with the Quality and Engineering teams to create a solution and implement the solution. Provides input for and 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. 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.

Adhere to safety protocols and PPE requirements in 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. Additional responsibilities as outlined in the full job description. Perform other duties as assigned.

Qualifications

Ability to automatically pivot in a fast-paced work environment. The ability to effectively manage inspection and packaging personnel. 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: High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred). Experience: Minimum of 7 years’ experience in a regulated manufacturing environment or equivalent education and experience.

Preferred Skills

Quality certification(s) (e.g., ASQ CQT, QCI, etc.) Knowledge of and experience with GMP/ISO standards. Physical Requirements: Ability to bend, stoop, squat, kneel, and lift to 50 pounds. Team lifts or mechanical assistance is required for objects over 50 pounds. Exposure to oil, grease, dust, metal particles, sparks, and sharp-edged materials.

Some exposures may require the use of personal protective equipment or engineering controls. 20/20 vision (assisted or unassisted) required for sorting raw and non-conforming materials. Good dexterity is needed for managing small to medium products. Ability to sit or stand for prolonged periods. Perform keyboard entries with possible frequent operation of a computer.

TOMZ is an Equal Opportunity Employer