We are looking for a motivated and curious CAPA & Nonconformance Specialist to support quality investigations and improvements within a regulated medical device environment. This temporary position offers a unique opportunity to gain hands-on experience in quality systems, investigations, and cross-functional collaboration within the pharmaceutical/medical device industry. You will work in an international and dynamic environment where communication, ownership, and collaboration are key.
Key Responsibilities
- Support and coordinate investigations of product and process nonconformances using structured root cause analysis tools (e.g., 5 Whys, Fishbone, basic Fault Tree Analysis)
- Drive and track CAPA and NC records from initiation to closure, ensuring clear documentation and timely follow-up
- Support the team in improving documentation, SOPs and quality processes
- Collaborate closely with Manufacturing, Quality, Supply Chain and other stakeholders to implement effective and sustainable solutions
- Assist in monitoring Key Performance Indicator (KPI) trends and identify recurring issues or improvement opportunities
- Contribute to audit readiness by supporting responses to audit observations and quality actions
Qualifications
- Bachelor's degree in Life Sciences, Engineering or a related field; advanced degree preferred.
- Strong technical writing skills
- 2-5 years of relevant experience in a regulated environment (medical device/pharma)
- Basic understanding of quality systems (CAPA/NC) or willingness to learn quickly
We are looking for someone who is:
- A quick learner with strong analytical thinking
- Curious, proactive and eager to develop within Quality / Pharma / Medical Devices
- Comfortable working in a dynamic and multicultural environment
- A strong communicator who can connect with different stakeholders and influence people in a constructive way
- Organized and able to manage multiple tasks and follow up on actions
Nice to have (not required)
- Familiarity with ISO 13485 / FDA QSR / EU MDR
- Experience with eQMS systems (e.g., EtQ, SAP)
- Experience with root cause analysis or Lean/Six Sigma tools
Additional Information
Working at PSS means working with highly motivated people with a can-do mentality. Our people work in an international environment, within an enthusiastic team and for an organization where there is sufficient room to develop further. Working together is extremely important to us and having fun in what you do is part of that! Our monthly team lunches, team activities and the hand out of awards to our colleagues are an example of this.
About the Company
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. Eurofins PSS Insourcing Solutions is a global, award-winning insourcing solution. We place our skilled team directly at the client site, managing operations seamlessly and eliminating complexities.