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.