Quality Control Engineer

Direct message the job poster from Established Search We are seeking a detail‑oriented and highly rigorous Quality Control Engineer to support the development and scale‑up of cutting‑edge medical technology. This role plays a critical part in ensuring product safety, reliability, and regulatory compliance through robust quality control, inspection, and documentation practices. You will work in a highly innovative environment focused on advanced medical devices, collaborating closely with Production, R&D, and Quality teams as products progress toward clinical application. Position Overview As a Quality Control Engineer, you will be responsible for designing, implementing, and executing quality control activities across components, equipment, and finished medical devices. You will ensure compliance with relevant standards while supporting continuous improvement initiatives and maintaining high‑quality system performance. This role is well suited to candidates with hands‑on QC or metrology experience within medical devices, biotech, or pharmaceutical environments. Key Responsibilities Quality Control Operations Design and implement quality control processes and associated documentation (procedures, work instructions, forms). Perform incoming, in‑process, and final inspections on components and finished medical devices. Manage clean room monitoring and surveillance, ensuring compliance with environmental and microbiological requirements. Oversee external service providers for microbiological testing and sterilization activities. Lead equipment qualification activities (IQ/OQ/PQ), internally and with suppliers. Define and execute equipment calibration and metrology activities in line with approved schedules. Ensure full traceability and accurate documentation of all QC activities within the Quality Management System (QMS). Compliance & Continuous Improvement Monitor and analyse quality KPIs, identifying trends and improvement opportunities. Manage quality control events including nonconformities, change controls, and CAPAs. Participate in internal and external audits, supporting continuous improvement initiatives. Ensure compliance with ISO 13485 and other applicable standards (e.g. ISO 17025, GLP, ICH). Collaboration & Technical Support Work closely with Production, R&D, and Quality Assurance teams to ensure product and process compliance. Provide technical guidance and mentoring to QC technicians. Support cross‑functional teams in maintaining high standards of safety, reliability, and performance. Qualifications & Experience Technical Requirements Strong working knowledge of ISO 13485; familiarity with ISO 17025, GLP, and ICH standards. Hands‑on experience with equipment calibration, IQ/OQ/PQ qualification, and dimensional or mechanical testing. Proficiency in measurement techniques, metrology, and quality documentation practices. Experience with microbiological testing and clean room environments is an advantage. Education & Background Master’s or Engineering degree in Quality, Metrology, Mechanical Engineering, Biomedical Engineering, or a related field. Minimum of 3 years’ experience in Quality Control or Metrology within medical devices, biotech, or pharmaceutical environments. Personal Attributes Highly detail‑oriented, analytical, and methodical. Proactive, autonomous, and solutions‑focused. Strong team player with the ability to work cross‑functionally. Excellent written and verbal communication skills in French and English. What’s on Offer Opportunity to work on highly innovative, mission‑driven medical technology. Collaborative environment with experienced engineers, scientists, and clinicians. Real ownership and responsibility within a growing, well‑funded organisation. Competitive benefits package including health insurance, meal vouchers, and transport reimbursement. #J-18808-Ljbffr