Quality Assurance Specialist – QMS & Compliance (m/f/d) in Hechingen

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.