Quality Engineer - QMS Integration

Key Role Details

Position: Quality Engineer - QMS Integration (Contract)
Duration: Until October 2026
Commitment: Full-time
Location: 70% - 80% on-site
Languages: Fluent German and English

Responsibilities

• NC & CAPA Leadership
  • Lead critical nonconformances and CAPAs from initiation to closure.
  • Ensure timely documentation, root cause identification, and implementation of corrections and corrective actions.
  • Provide progress reporting, escalation when needed, and stakeholder engagement across functions.
• QMS Integration & Procedure Development
  • Understand existing manufacturing processes and share insights with the integration team.
  • Partner with SMEs and integration team members to red‑line and refine procedures and other QMS documents.
  • Ensure all procedures remain compliant with regulatory and quality standards.
  • Review procedure drafts for efficiency, clarity, and alignment with actual shop‑floor practices.
• Training & Change Enablement
  • Support training of operations teams on new or updated processes, explaining the rationale and expected behaviors.
  • Provide input to influence remediation strategy based on real shop‑floor practices.
  • Support training of employees on updated processes and QMS expectations.
• Change & Document Control
  • Lead Change Control activities related to integration and remediation, using the existing system.
  • Lead Document Control activities and ensure accurate review and approval of changes, revisions, and documentation updates.
  • Ensure all changes and documentation are compliant, complete, and audit ready.
• Audit Readiness & Support
  • Support preparation for internal and external audits.
  • Ensure relevant documentation is up to date, accessible, and aligned with integration progress.
• Deliverables & Expected Outcomes
  • Timely and accurate execution and documentation of all assigned changes.
  • Audit‑ready documentation for any integration or remediation activities.
  • Clear and consistent communication with stakeholders across Quality, Operations, and Integration.

Candidate Requirements

• Minimum ~2 years in RAQA / Quality Engineering (ideally MedTech)
• Strong experience with NC/CAPA , Change Control, Document Control
• Hands-on understanding of manufacturing processes
• Experience working in regulated environments
• Ability to support procedure redlining and shop-floor aligned process design
• Strong communication and training capabilities
• German fluency + English C1

Nice-to-Haves

• TrackWise experience
• Problem-solving methodologies (e.g., 5 Whys, RCA, DMAIC)
• Project management exposure

SThree_Germany is acting as an Employment Business in relation to this vacancy.