Quality Cell Lead: Medical Device QA & Improvement

TOMZ Corporation; Big Lake (MN); On-site; USD 41,000 - 58,000; Full time

Job summary

TOMZ Corporation in Big Lake, MN is hiring a Quality Cell Lead to manage quality control on the production floor for medical device components. You will lead inspections, ensure DHR/DMR GDP compliance, and drive continuous improvement within a GMP/ISO environment.

The role requires at least 6 years in a regulated manufacturing setting, strong measurement equipment skills, and leadership ability to guide a quality team on the shop floor.

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.)

Responsibilities

• Performs inspections on machined components and assemblies using visual and layout inspection techniques.
• Creates, completes, and compiles necessary documentation related to Quality Inspection standards.
• Ensure proper material control, identification and traceability for conforming and nonconforming material.
• Supports record retention and reviews Device History Records and GDP compliance.
• Utilize ERP to prioritize product final acceptance and shipment when needed.
• Follow Safety and PPE guidelines and TOMZ Quality Management System.
• Lead continuous improvement efforts aligned with GDP/GMP standards.
• Record nonconformities and manage MRB; coordinate containment actions and root cause analysis.
• Provide coaching and performance input to Quality Control staff.
• Perform complex inspections using comparators, CMM, vision systems, and automated methods.
• Provide basic programming assistance for inspection methods.
• Execute First Piece and FAI inspections as assigned.
• Align workload and set targets for performance; assist other Quality functions.

Skills

Blueprint reading

Inspection techniques

English communication

Team leadership

Quality documentation

Education

High school diploma or equivalent

Tools

Micrometers

Calipers

Dial indicators

Height gauges

Job description

TOMZ Corporation in Big Lake, MN is hiring a Quality Cell Lead to manage quality control on the production floor for medical device components. You will lead inspections, ensure DHR/DMR GDP compliance, and drive continuous improvement within a GMP/ISO environment.

The role requires at least 6 years in a regulated manufacturing setting, strong measurement equipment skills, and leadership ability to guide a quality team on the shop floor.