Quality Engineer - Medical Devices, Design Controls

TOMZ Manufacturing Corp; Big Lake (MN); On-site; USD 70,000 - 100,000; Full time

Job summary

TOMZ Manufacturing Corp in Big Lake, MN is seeking a Quality Engineer to lead design and development quality activities within PDP, while supporting ongoing manufacturing. The role involves risk management collaboration, test method validation, and supplier qualification in a regulated environment.

Ideal candidates have 2–5 years’ experience in a regulated manufacturing setting, familiarity with GMP/GDP, GD&T, and strong English communication.

Qualifications

• Knowledge of statistical techniques to analyze process capability.
• Quality certifications (e.g., ASQ CQE, QCI).
• Skilled in First Article Inspections and Component Qualifications.
• Knowledge of ISO 9001/9000, ISO 13485, 21 CFR 820, EU MDR requirements.
• Experience supporting audits by customers and regulatory agencies.

Responsibilities

• Develop and execute Quality Plans for product design and development.
• Collaborate with engineering to update Risk Management documentation.
• Support qualification audits for customers and regulatory agencies.
• Drive Test Method Validation with V&V rationale.
• Implement inspection plans for Incoming, In-Process and Final Product.
• Maintain QMS compliance and provide training as needed.

Skills

Statistical techniques

Strong verbal and written English

Problem solving

Self-starter

Team collaboration

Education

4-year degree in Engineering or Quality

Tools

Microsoft Office

Job description

TOMZ Manufacturing Corp in Big Lake, MN is seeking a Quality Engineer to lead design and development quality activities within PDP, while supporting ongoing manufacturing. The role involves risk management collaboration, test method validation, and supplier qualification in a regulated environment.

Ideal candidates have 2–5 years’ experience in a regulated manufacturing setting, familiarity with GMP/GDP, GD&T, and strong English communication.