Staff Quality Engineer

Responsibilities

• Lead supplier qualification, approval, auditing, performance monitoring, and quality improvement activities supporting both development and commercial manufacturing programs.
• Partner with product development teams early in the design process to define supplier requirements, assess quality risks, and support manufacturability decisions.
• Evaluate and oversee contract manufacturing partners, including quality assessments, audits, quality agreements, and ongoing performance management.
• Support manufacturing strategy, design transfer, process development, validation, and manufacturing readiness activities for new product introductions.
• Identify and mitigate supplier, manufacturing, and operational risks that could impact product quality, regulatory compliance, supply continuity, or patient safety.
• Develop and maintain quality plans, inspection strategies, process controls, and monitoring programs that support global regulatory requirements.
• Provide technical leadership across supplier quality, operations quality, and quality systems while collaborating with engineering, manufacturing, regulatory, and program teams.
• Drive continuous improvement initiatives that strengthen supplier performance, process capability, manufacturing effectiveness, and product reliability.
• Preferred Requirements
• Bachelor's degree in Engineering, Science, or a related technical discipline, combined with significant Quality Engineering experience within medical devices or another regulated industry.
• Experience supporting both supplier quality and operations quality activities, ideally within new product development, design transfer, or commercialization programs.
• Demonstrated expertise in supplier qualification, supplier development, auditing, contract manufacturing oversight, and quality issue resolution.
• Strong knowledge of ISO 13485, MDR, FDA Quality System requirements, risk management principles, and quality systems within regulated environments.
• Experience using quality engineering and problem-solving tools such as SPC, process capability analysis, Gage R&R, acceptance sampling, 8D, and CAPA methodologies.
• Exposure to home-care technologies, connected medical devices, infusion systems, or other complex electromechanical products would be advantageous.
• The expected base salary for this role is in the region of €75,000 to €90,000 per year. Please note that this is a more representative range than the wider salary band shown at the end of the advertisement. The successful candidate will also be eligible for an annual bonus, alongside a range of additional benefits. Please note that a different salary range will apply to candidates based in the UK, reflecting local market conditions and compensation structures.
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