Design Quality Assurance Engineer, Medical Devices

What your day looks like

Reporting to the Quality Engineering Manager, you begin the day partnering with R&D to shape quality activities across the Product Development Process (PDP). You translate design intent into Quality Design & Development (QD&D) controls, map risks, and set a verification and validation path that stands up to customer and regulatory scrutiny. By midday, you’re defining severity- and risk-based Process Master Validation Plan strategies with clear V&V rationales and coordinating operational and process qualifications for customer manufacturing processes alongside engineering teams.

Afternoons often focus on test method work: you help craft robust test methods with operational and business needs in mind, then drive Test Method Validations to prove they measure what matters. You also implement inspection plans—Incoming, In-Process, and Final—and develop statistically sound sampling plans grounded in method characterization. Throughout the day, you represent Quality Engineering in design reviews, support qualification audits by customers and regulatory bodies, and engage suppliers with audits and assessments to ensure design characterization requirements are met. You advance Quality Best Practices and continuous improvement in GDP/GMP, apply structured problem-solving to quality issues, and ensure site personnel comply with the site-level Quality Management System and training. You support the development of Quality Agreements for external customers and adhere to the TOMZ Quality Management System. Other related duties may be assigned as projects evolve.

Key responsibilities

• Own QD&D controls across PDP and sustaining manufacturing/distribution support.
• Initiate and maintain Risk Management documentation per project requirements.
• Establish risk-based Process Master Validation Plan strategies with solid V&V rationale.
• Lead/Support operational and process qualifications for customer manufacturing processes.
• Develop test methods and execute Test Method Validations for effectiveness.
• Deploy inspection plans for Incoming, In-Process, and Final Product.
• Build statistically justified sampling plans tied to method characterization.
• Serve as the Quality voice in design reviews.
• Support initial qualification audits by customers and regulatory agencies.
• Audit suppliers; verify vendor design characterization requirements for projects.
• Champion Quality Best Practices; drive continuous improvement in GDP/GMP.
• Use systematic problem-solving to prioritize and resolve quality issues.
• Ensure site-wide adherence to the Quality Management System and training needs.
• Contribute to Quality Agreements for external customers.
• Adhere to the TOMZ Quality Management System.

Qualifications

• Advanced post-secondary education, training, or certification; quality certifications (e.g., ASQ CQE, QCI) are valued.
• Proficiency in statistical techniques for process capability analysis.
• Expertise in First Article Inspections (FAI) and component qualifications; strong GD&T understanding.
• Working knowledge of ISO 9001, ISO 13485, 21 CFR 820, and EU MDR across design controls, GMP, supplier qualification, auditing, quality control (Nonconforming Materials, MRB), CAPA, and customer complaints.
• Experience supporting customer and external regulatory audits.
• Clear, professional English communication (written and verbal).
• Ability to meet TOMZ-specific positional and functional on-the-job training.
• Proficient with Microsoft Office.
• Self-starter who collaborates across R&D, Manufacturing, and QA to deliver results.

Education

Minimum 4-year degree or directly transferrable industry experience equivalent (Engineering or Quality discipline preferred).

Experience

• 2–5 years in a regulated manufacturing environment.
• Background with Class I, II, and/or III medical devices within regulated industries (e.g., Aerospace, Defense, Pharmaceutical).

Physical requirements

• Ability to bend, stoop, squat, kneel, and lift up to 50 lbs; team lift or mechanical assistance required over 50 lbs.
• Ability to sit for prolonged periods.
• Potential exposure to oil, grease, occupational noise, cleaning solvents, dust, metal particles, sparks, coolant, and sharp edges; PPE such as safety glasses, dust masks, ear plugs, cut-resistant or chemical-resistant gloves, and engineering controls may be required.
• Frequent computer use and keyboard entry.