Quality Engineer - QMS Integration

Stellenbeschreibung:

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.

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NOTE / HINWEIS:
EnglishEN: Please refer to Fuchsjobs for the source of your application
DeutschDE: Bitte erwähne Fuchsjobs, als Quelle Deiner Bewerbung

Stelleninformationen

  • Veröffentlichungsdatum:

    09 Feb 2026
  • Standort:

    WorkFromHome
  • Typ:

    Vollzeit
  • Arbeitsmodell:

    Vor Ort
  • Kategorie:

    Development & IT
  • Erfahrung:

    2+ years
  • Arbeitsverhältnis:

    Angestellt

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