*About the Company**
We are looking for a Quality Assurance Specialist – QMS \& Compliance to strengthen the effectiveness, compliance and continuous improvement of our Quality Management System within a regulated medical\-device environment.
*About the Role**
This role combines internal and supplier auditing, CAPA and nonconformity management, complaint handling, supplier quality and cross\-functional process improvement. You will work closely with process owners and technical stakeholders to identify compliance gaps, solve systemic quality issues and develop robust, practical and sustainable processes.
*Responsibilities**
Plan, conduct, document and follow up internal Quality Management System audits in accordance with ISO 13485, EU MDR, company procedures and other applicable requirements.
* Conduct or support risk\-based supplier audits and follow supplier findings and corrective actions through effective closure.
* Support preparation for and participation in Notified Body, regulatory and other external audits or inspections.
* Coordinate and support CAPAs from initiation through root\-cause investigation, action implementation, effectiveness verification and closure.
* Facilitate structured root\-cause analysis and constructively challenge weak investigations or symptom\-based corrective actions.
* Monitor CAPA and nonconformity trends, timelines and effectiveness and support escalation of systemic or overdue issues.
* Support complaint receipt, assessment, investigation, documentation, trending and closure in close collaboration with relevant technical functions.
* Work closely with Regulatory Affairs/Vigilance and ensure timely escalation of complaints potentially meeting vigilance/reportability criteria.
* Collaborate with process owners and stakeholders to develop, simplify and continuously improve QMS processes while maintaining regulatory compliance.
* Support supplier qualification, supplier quality issues, deviations, CAPAs, quality agreements and change assessments.
* Contribute to QMS metrics, Management Review, inspection readiness and continuous quality\-system improvement.
*Qualifications**
University degree in engineering, medical technology, natural sciences, life sciences or another relevant technical/scientific discipline is preferred; an equivalent technical qualification combined with strong relevant QA experience may also be considered.
* Approximately 3–5 years of relevant experience in Quality Assurance, Quality Systems, Supplier Quality or Quality Management, preferably in the medical\-device industry.
*Required Skills**
Practical knowledge of ISO 13485 and working knowledge of EU MDR.
* Experience with internal audits and/or supplier audits.
* Practical experience with CAPA, nonconformities/deviations and structured root\-cause investigation.
* Understanding of complaint handling and the interface with Regulatory Affairs/Vigilance.
* Strong analytical, problem\-solving and process\-improvement capability.
* Ability to assess objective evidence critically and constructively challenge inadequate investigations, corrective actions or processes.
* Structured, precise and independent working style with strong documentation and report\-writing skills.
* Strong communication and stakeholder\-management capability and confidence interacting with process owners and external suppliers.
* Strong professional English; Very good German is strongly preferred.
*Preferred Skills**
Supplier\-audit and supplier\-quality experience.
* Internal Auditor or Lead Auditor training/qualification and knowledge of ISO 19011\.
* Experience with Notified Body audits or regulatory inspections.
* Class III and/or implantable medical\-device experience.
* Complaint trending, Vigilance/PMS interface, FDA QMSR or MDSAP experience.
* Experience with process mapping, Lean or other structured continuous\-improvement methodologies.
*Equal Opportunity Statement**
We are committed to diversity and inclusivity.
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