Linkedprime

Job Description

Senior CAPA EngineerAre you passionate about quality, problem-solving, and driving impactful change?Our client sees CAPAs as more than a process – they are cornerstones in quality systems and critical to ensuring safe, effective, and life-changing medical devices for patients worldwide.We are looking for an experienced Senior CAPA Engineer, and in this role, you will not only lead CAPA cases from initiation to closure but also coach and guide subject matter experts across the organisation. Your ability to challenge, mentor, and ensure robust root cause analyses will be key in building lasting solutions that truly make a difference.What you’ll doAct as the primary driver of the CAPA process, ensuring effective planning, facilitation, and timely executionMentor and support subject matter experts in problem-solving and solution implementationLead root cause analyses using structured tools (e.g., 5 Whys) to identify and address real issuesVerify the effectiveness of implemented solutions, making sure problems don’t returnWhat you bringProven experience managing CAPAs end-to-end in a regulated industry (MedTech, Pharma, or similar)Strong knowledge of standards and regulatory requirements, including ISO 13485 and MDR 2017/745A scientific, technical, or engineering background (advantageous)Fluency in Danish and EnglishA collaborative mindset, strong communication skills, and a passion for quality and continuous improvementWhy join?With more than 10,000 colleagues worldwide, our client is driven by the same mission: to improve patients’ lives with innovative, minimally invasive medical solutions.In Denmark, they are 700 employees, and openness, collaboration, and dedication to quality define their culture.The offerA comprehensive onboarding and training programFlexible work arrangements and home office equipmentCompetitive salary package with bonus and pensionHealth insurance, great canteen, fitness facilities, and social activitiesA workplace where determination, loyalty, humour, and teamwork are valuedIf you are motivated by driving high-quality solutions, building strong relationships, and making a real impact, we’d love to hear from you.

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