Risk Management & Validation Quality Engineer (ISO 13485)

Join us to raise the bar on product quality

As a Quality Engineer reporting to the Quality Engineering Manager, you will lead quality activities through new product development and into sustaining manufacturing and distribution. Your mission is to architect QD&D controls, mitigate risk, and ensure verification and validation rigor that satisfies customers and regulators alike.

Your impact

• Develop comprehensive Quality Plans for product design and development initiatives.
• Partner with engineering to create and maintain project-specific Risk Management files.
• Define severity- and risk-based Process Master Validation Plan strategies with strong V&V rationale.
• Support/lead operational and process qualifications for customer manufacturing processes.
• Design test methods aligned to operational and business needs; execute Test Method Validations to confirm effectiveness.
• Implement robust inspection plans across Incoming, In-Process, and Final Product stages.
• Set statistically justified sampling plans grounded in measurement characterization.
• Represent Quality Engineering in cross-functional design reviews.
• Prepare for and support customer and regulatory initial qualification audits.
• Qualify and monitor suppliers through audits and assessments; verify vendor design characterization requirements.
• Advance Quality Best Practices; drive continuous improvement in GDP/GMP.
• Use structured problem-solving to identify, prioritize, communicate, and resolve quality issues.
• Promote adherence to the site-level Quality Management System and training.
• Contribute to Quality Agreements for external customers and adhere to the TOMZ Quality Management System.
• Perform additional related duties as assigned.

What you bring

• Advanced post-secondary education/training; quality certifications (ASQ CQE, QCI, etc.) preferred.
• Applied statistics skills for process capability analysis.
• Hands-on with First Article Inspections (FAI) and component qualifications; strong GD&T.
• Demonstrated 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 handling customer complaints.
• Proven success supporting customer and external regulatory audits.
• Excellent English communication skills, written and verbal.
• Ability to complete TOMZ-specific on-the-job training requirements.
• Microsoft Office proficiency.
• Independent, self-driven, and collaborative across R&D, Manufacturing, and QA.

Education

Minimum bachelor’s degree or equivalent directly transferrable industry experience (Engineering or Quality preferred).

Experience

• 2–5 years in regulated manufacturing.
• Experience with Class I, II, and/or III medical devices; exposure to other regulated sectors (Aerospace, Defense, Pharmaceutical) is a plus.

Physical requirements

• Frequent bending, stooping, squatting, kneeling; lift up to 50 lbs (team/mechanical assist required over 50 lbs).
• Prolonged sitting.
• Possible exposure to oil, grease, occupational noise, cleaning solvents, dust, metal particles, sparks, coolant, sharp edges; PPE (safety glasses, dust masks, ear plugs, cut-resistant or chemical-resistant gloves) and engineering controls may be required.
• Frequent computer and keyboard use.