Quality Engineer

• 24 August 2026
• 80 - 100%
• Indefinite duration
• English (Fluent), French (Native language)
• Route de Chardonne 4, 1070 Puidoux
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Join a key player in medical micro-manufacturing

At Resonetics, we push the boundaries of micro-manufacturing in service of medical devices and diagnostics. Our cutting-edge technologies allow our customers to innovate and improve the lives of patients around the world.

Our Puidoux site, which has 150 employees, is a strategic supplier of precision metal tubing and components for medical devices. In a context of growth and strong regulatory requirements, we are strengthening our quality team.

We are looking for an experienced Quality Engineer, ready to play a central role in the quality performance of our site.

Your mission

As a Quality Engineer, you play a key role in maintaining and improving our Quality Management System and support operational teams in controlling our products and processes.

A true partner to Production, Quality Control, Engineering/NPI, as well as our customers and suppliers, you intervene close to operations to prevent risks, resolve quality issues, and contribute to the continuous improvement of our performance.

You will evolve in a technical, international, and highly regulated environment, where your expertise contributes directly to the reliability of components intended for innovative medical devices.

Your responsibilities

? Quality Management System

• Contribute to the maintenance and continuous improvement of the Quality Management System (QMS) in accordance with applicable requirements, notably ISO 13485
• Write, revise, and maintain quality procedures, instructions, and records
• Participate in the initial and ongoing training of employees on QMS requirements
• Plan and conduct internal audits and ensure the follow-up of associated action plans
• Participate in the preparation and follow-up of customer audits and certification audits
• Contribute to normative and regulatory monitoring applicable to the site

? Operational quality & problem solving

• Ensure the processing and follow-up of non-conformities (NCMR), from their investigation to their closure
• Lead quality investigations and root cause analyses using structured methodologies such as 5 Why, Ishikawa, 8D or DMAIC
• Define, implement, and monitor corrective and preventive actions (CAPA) and verify their effectiveness
• Participate in the processing of customer complaints, conduct associated investigations, and contribute to the preparation of customer responses
• Be the Quality point of contact during daily Tier 2 meetings, in collaboration with Production, NPI, and Engineering teams, in order to identify, prioritize, and resolve operational and quality issues
• Provide daily quality support to Production, QC, and Engineering/NPI teams
• Participate in the definition, development, and improvement of control plans
• Contribute to product and process risk analyses (FMEA / AMDEC)
• Use appropriate statistical tools to analyze and improve process performance: SPC, MSA, Gage R&R, Cp/Cpk capability studies, trend analyses, etc.
• Participate in Lean initiatives, non-conformity reduction, and continuous improvement

? Validation & process control

• Participate in the validation and revalidation of equipment, processes, and control methods (IQ/OQ/PQ)
• Contribute to the definition of acceptance criteria and the analysis of validation results
• Participate in FAI / PPAP activities and other quality files specific to customer requirements
• Evaluate the quality impact of changes to products, processes, equipment, or methods within the framework of Change Control
• Contribute to ensuring the control and robustness of manufacturing processes

? Customer & supplier interface

• Be a preferred quality interlocutor for customers on subjects within your scope
• Participate in technical and quality exchanges with customers as well as reviews of applicable requirements
• Contribute to the evaluation of modification requests and specific customer quality requirements
• Participate in the evaluation and follow-up of supplier quality performance
• Conduct or participate in supplier audits
• Collaborate with the various Resonetics group entities on transverse quality issues and projects

Your profile

• Bachelor's degree in engineering, quality, materials science, mechanics, microtechnology, or equivalent technical training
• Minimum 5 years of experience in quality engineering, ideally in the medical device field or in a highly regulated industrial environment
• Good mastery of ISO 13485 standard requirements
• Practical experience in managing non-conformities, CAPA, customer complaints, and root cause analysis
• Good knowledge of problem-solving and risk analysis tools: 8D, 5 Why, Ishikawa, FMEA/AMDEC
• Solid skills in SPC, MSA, Gage R&R, and capability studies
• Experience in process and equipment validation (IQ/OQ/PQ) is a significant asset
• Excellent mastery of French and professional fluent English, both written and spoken
• Comfortable in an industrial environment and close to operations
• Analytical mindset, rigor, and ability to structure and prioritize activities
• Autonomy, pragmatism, and a strong problem-solving orientation
• Excellent communication skills and ability to work with multidisciplinary and international teams

What we offer you

• A key and transverse role with an impact