Quality Engineer - QMS Integration

SThree; Baden-Württemberg; Hybrid; EUR 60.000 - 75.000; Vollzeit

Zusammenfassung

A leading recruitment agency is seeking a Quality Engineer specializing in QMS Integration for a full-time contract position in Germany. The role involves leading CAPAs, ensuring procedural compliance, and preparing for audits. Candidates should have around 2 years of experience in Quality Engineering, ideally in MedTech, with skills in NC/CAPA and Change Control. Fluency in German and English is required, and the position emphasizes strong communication and training capabilities.

Qualifikationen

• Minimum ~2 years in RAQA / Quality Engineering, ideally in MedTech.
• Strong experience with NC/CAPA, Change Control, Document Control.
• Hands-on understanding of manufacturing processes.

Aufgaben

• Lead critical nonconformances and CAPAs from initiation to closure.
• Ensure timely documentation and implementation of corrective actions.
• Support training of operations teams on new or updated processes.

Kenntnisse

Quality Management

Regulatory Compliance

Training Capabilities

Problem-solving

Jobbeschreibung

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

Key Responsibilities

• 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.
• 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

Nice-to-Haves

• Problem-solving methodologies (e.g., 5 Whys, RCA, DMAIC)