CAPA & Nonconformance Specialist

Eurofins PSS Insourcing Solutions® is a global insourcing solution, placing skilled teams directly at client sites to manage operations and support cGMP-compliant work within regulated environments.

This role is for a CAPA & Nonconformance Specialist to support quality investigations and improvements within a regulated medical device environment. This temporary position (until 31-Dec-2026) 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

What we offer

• A responsible and challenging position within the team
• Plenty of room for your own ideas and input
• Specialist training and a range of opportunities for personal and professional development
• Online preventive mental health platform
• Flexible working hours
• Good salary and benefits