Quality Engineer

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Lumitex has been at the forefront of medical lighting solutions for nearly 40 years, striving to become the global leader in medical device lighting and to improve life with light. We collaborate with customers to integrate light into applications, to treat or prevent specific medical conditions, and to overcome complex lighting challenges. Our comprehensive services combine product development, engineering expertise, and lighting system production to optimize light and improve the standard of patient care.

This role focuses on providing thorough and practical solutions to a wide range of technical problems through the application of quality, statistical, and engineering disciplines.

• Participate in design quality activities; develop and implement part and process qualification requirements to ensure delivered products meet specification and quality/reliability requirements.
• Lead and support executing, documenting, and investigating supplier and internal non-conformance reports (NCRs).
• Lead and support the Customer Return Authorization (RMA) process and initiate investigation efforts to address and reduce customer complaints through effective root cause investigation and corrective action.
• Lead and support CAPA controls, completion, implementation and effectiveness stages.
• Lead and support factory PPAP and IQ/OQ/PQ actions to maintain high quality production.
• Support risk analysis activities; demonstrate proficiency in applying various risk management and risk mitigation tools and practices.
• Support internal auditing program – conduct process, product and QMS internal audits. Assist in managing QMS auditing program as needed.
• Support inspection team in daily functions.
• Use quality tools and analysis to formulate and facilitate quality plans for products.
• Develop, maintain, and ensure compliance with quality assurance programs, policies, processes, and procedures under customer, internal, ISO 9001, FDA, ISO 13485, and regulatory/legal requirements.
• Review and approve changes in product, documentation and processes through the Change Control Process.

• Bachelor’s degree in engineering, science, or equivalent.
• 1-5 years quality assurance experience, with Medical Device experience strongly preferred.

• Strong problem‑solving skills and attention to detail.
• Develop standardized component test methods.
• Create Process Risk Analysis Documentation.
• Component characterization using smart inspection equipment.
• Device life testing.
• Develop visual inspection protocol.
• Hands‑on medical device assembly.
• Production line qualification and validation.
• Self‑motivated with critical attention to detail, deadlines, and reporting.

• Knowledge of ISO and Lean, PPAPs, PFMEA, and Control Plans, tools and techniques preferred.

• Speak, stand, talk, walk, sit, see, and hear regularly.
• Occasionally climb, stoop, kneel, crouch, or crawl.
• Occasionally lift and/or move up to 50 pounds.

Lumitex is an equal opportunity employer and does not discriminate on the basis of race, color, religion, gender (including pregnancy), sexual orientation, gender identity, national origin, age, disability, genetic information, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state and local laws. Lumitex complies with applicable state and local laws governing nondiscrimination in employment.