Quality Engineer

About the job

Join a key player in medical micro-manufacturing

At Resonetics, we push the boundaries of micro-manufacturing in the service of medical devices and diagnostics. Our cutting-edge technologies enable our clients to innovate and improve patients’ lives worldwide.

Our Puidoux site, with 150 employees, is a strategic supplier of high-precision metal tubes and components for medical devices. In a context of growth and stringent 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 of Production, Quality Control, Engineering/NPI as well as our clients and suppliers, you work closely with operations to prevent risks, resolve quality issues and contribute to the continuous improvement of our performance.

You operate in a technical, international and highly regulated environment, where your expertise directly contributes 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, review and maintain quality procedures, instructions and records
• Participate in initial and ongoing training of employees on QMS requirements
• Plan and conduct internal audits and ensure follow-up of associated action plans
• Participate in preparation and follow-up of client audits and certification audits
• Contribute to regulatory and normative watch applicable to the site

🔹 Operational quality & problem resolution

• Ensure handling and follow-up of non-conformities (NCMR), from investigation to 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 handling client complaints, conduct associated investigations and contribute to preparing client responses
• Be the Quality referent during daily Tier 2 meetings, in collaboration with Production, NPI and Engineering teams, to identify, prioritise and resolve operational and quality issues
• Provide daily quality support to Production, QC and Engineering/NPI teams
• Participate in defining, developing and improving control plans
• Contribute to product and process risk analyses (FMEA / AMDEC)
• Use appropriate statistical tools to analyse and improve process performance: SPC, MSA, Gage R&R, capability studies Cp/Cpk, trend analyses, etc.
• Participate in Lean initiatives, reduction of non-conformities and continuous improvement

🔹 Validation & process control

• Participate in validations and revalidations of equipment, processes and control methods (IQ/OQ/PQ)
• Contribute to defining acceptance criteria and analysing validation results
• Participate in FAI / PPAP activities and other quality files specific to client requirements
• Evaluate the quality impact of product, process, equipment or method changes within Change Control
• Contribute to ensuring control and robustness of manufacturing processes

🔹 Client & supplier interface

• Be a preferred quality contact for clients on topics within your scope
• Participate in technical and quality exchanges with clients as well as reviews of applicable requirements
• Contribute to evaluating change requests and specific client quality requirements
• Participate in evaluations and monitoring of supplier quality performance
• Lead or participate in supplier audits
• Collaborate with various Resonetics group entities on transversal quality issues and projects

Your profile

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

What we offer you

• A key and cross-functional role with direct impact on the quality of components for medical devices
• A high-precision, technologically demanding and stimulating industrial environment
• Close proximity to production, engineering and clients
• An engaged and collaborative team
• Varied projects and interactions with international clients and teams
• The opportunity to contribute concretely to the improvement and transformation of our quality processes
• Professional development opportunities within a growing international group

At Resonetics, we value excellence, commitment and team spirit. If you wish to contribute to innovative projects in a dynamic environment, we would be delighted to hear from you.

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