Quality Engineer

Quality Engineer
Join a key player in medical micro-fabrication
At Resonetics, we push the boundaries of micro-fabrication to serve 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 metal tubes and high-precision 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 mastering our products and processes.
A true partner to Production, quality control, Engineering/NPI as well as our customers and suppliers, you intervene closely to 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 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 continuous 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 the regulatory and normative 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 referent during daily Tier 2 meetings, in collaboration with the Production, NPI and Engineering teams, in order to identify, prioritize and resolve operational and quality issues
Provide daily quality support to the 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 contact for customers on matters 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 monitoring of supplier quality performance
Conduct or participate in supplier audits
Collaborate with the different entities of the Resonetics group on transverse quality issues and projects
Your profile
Bachelor's degree in engineering, quality, materials science, mechanics, microtechnics 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 with process and equipment validations (IQ/OQ/PQ) is a significant asset
Excellent command of French and fluent professional English, both written and oral
Comfortable in an industrial environment and close to operations
Analytical mind, rigor and ability to structure and prioritize 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 transverse role with a direct impact on the quality of components intended for medical devices
A high-precision, technologically demanding and stimulating industrial environment
Strong proximity to production, engineering and customers
An engaged and collaborative team
Varied projects and intera