CAPA & Nonconformance Specialist
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Job Location:
Nijmegen - Netherlands
Monthly Salary:
Not Disclosed
Posted on:
12 hours ago
Vacancies:
1 Vacancy
Job Summary
We are looking for a motivated and curious CAPA & Nonconformance Specialist to support quality investigations and improvements within a regulated medical device 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 :
- Bachelors degree in Life Sciences Engineering or a related field; advanced degree preferred.
- Strong technical writing skills
- 25 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. We also 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.
Working at PSS offers you the flexibility and personal touch of working in a medium sized and dynamic company whilst also allowing you to benefit from having Eurofins as a parent company. Our ambitious growth plans provide ample opportunities for the motivated employees:
- Plenty of opportunities for growth;
- Varied work where you are in regular contact with other companies and scientists within the Eurofins group;
- A broad customer portfolio ensuring a lot of diversity in your work.
Would you like to know more
For questions regarding the position please follow the link below Im interested in order to contact the hiring manager.
Acquisition for this vacancy is not appreciated.
Remote Work :
No
Employment Type :
Full-time
Key Skills
- Sales Experience
- Crane
- Customer Service
- Communication skills
- Heavy Equipment Operation
- Microsoft Word
- Case Management
- OSHA
- Team Management
- Catheterization
- Microsoft Outlook Calendar
- EHS
About 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 the environment safer, healthier and more sustainable. From the food you eat to the medicines you rely on, Eur ... View more
