CAPA & Nonconformance Specialist
Eurofins is seeking a motivated and curious CAPA & Nonconformance Specialist to support quality investigations and improvements within a regulated medical device environment. This temporary position, available until December 31, 2026, offers a unique opportunity to gain hands-on experience in quality systems, investigations, and cross-functional collaboration within the pharmaceutical and medical device industry. The role is situated within an international and dynamic environment where communication, ownership, and collaboration are key.
The primary responsibilities include supporting and coordinating investigations of product and process nonconformances using structured root cause analysis tools such as 5 Whys, Fishbone, and basic Fault Tree Analysis. The specialist will drive and track CAPA and NC records from initiation to closure, ensuring clear documentation and timely follow-up. Additional duties involve improving documentation, standard operating procedures, and quality processes, as well as collaborating closely with Manufacturing, Quality, Supply Chain, and other stakeholders to implement effective and sustainable solutions. Monitoring Key Performance Indicator trends and identifying recurring issues or improvement opportunities are also key aspects of the role.
Candidates should possess a bachelor's degree in Life Sciences, Engineering, or a related field, with an advanced degree preferred. Strong technical writing skills and 2–5 years of relevant experience in a regulated environment, such as medical devices or pharmaceuticals, are required. A basic understanding of quality systems, including CAPA and NC, or a willingness to learn quickly, is essential. The ideal candidate is a quick learner with strong analytical thinking, proactive, and eager to develop within the Quality, Pharma, or Medical Devices sectors. Comfort in a dynamic and multicultural environment, strong communication skills to connect with various stakeholders, and the ability to manage multiple tasks and follow up on actions are important attributes.
While not mandatory, familiarity with ISO 13485, FDA QSR, EU MDR, experience with electronic Quality Management Systems like EtQ or SAP, and knowledge of root cause analysis or Lean/Six Sigma tools are advantageous. Eurofins offers a responsible and challenging position within the team, ample room for personal ideas and input, specialist training, and a range of opportunities for personal and professional development. Additional benefits include access to an online preventive mental health platform, flexible working hours, and a competitive salary and benefits package.
Working at Eurofins PSS Insourcing Solutions® means being part of a team with a can-do mentality in an international environment. The organization values collaboration and enjoyment in work, as evidenced by monthly team lunches, team activities, and recognition awards for colleagues. Eurofins' ambitious growth plans provide ample opportunities for motivated employees, offering varied work with regular contact with other companies and scientists within the Eurofins group, ensuring diversity in daily tasks.