Validation Engineer
Freiburg
Contract
Negotiable
Quality
CR/611073_1790062956
Validation Engineer
9-12 Month Contract with potential extension
4+ Days On-Site
Baden-Württemberg
We're supporting a leading global medical device organisation looking for an experienced Quality Engineer with a strong focus on Quality Systems to join their team on an initial 9-12 month contract, with a higher potential for extension.
This is a predominantly on-site position, requiring at least 4 days per week on site.
What You'll Do
- Maintain and continuously improve the Quality Management System (QMS)
- Manage CAPAs, non-conformances and change controls
- Lead and support Root Cause Analysis (RCA) and investigations
- Support internal, external and regulatory audits
- Review and maintain SOPs and quality documentation
- Monitor quality metrics and identify continuous improvement opportunities
- Support document control, training and compliance activities
- Partner with Quality, Regulatory, Engineering and Operations teams
What We're Looking For
- A minimum of 2-3 years of quality experience within medical devices or another highly regulated industry
- Strong knowledge of ISO 13485 and Quality Management Systems
- Hands-on experience with CAPA, RCA, non-conformances and audits
- Knowledge of EU MDR, FDA QMSR and/or MDSAP advantageous
- Strong communication, problem-solving and stakeholder management skills