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

Biosensors International Group, Ltd; Hechingen; Presencial; EUR 60 000 - 85 000; Tempo integral

Resumo da oferta

Biosensors International Group, Ltd is seeking a Quality Assurance Specialist – QMS & Compliance to strengthen the effectiveness and regulatory compliance of our QMS in a regulated medical-device environment. The role covers internal and supplier audits, CAPA management, nonconformities, and complaint handling.

You will work with process owners and regulatory affairs to close gaps, drive root-cause analysis and continuous improvement, and prepare for external audits.

Qualificações

• University degree (or equivalent technical qualification) in engineering, medical technology, natural sciences or life sciences is preferred.
• 3–5 years of experience in Quality Assurance/Quality Systems or Supplier Quality in the medical-device industry.
• Experience with ISO 13485 and EU MDR is required or highly desirable.

Responsabilidades

• Plan, conduct and document internal QMS audits in line with ISO 13485 and EU MDR.
• Support supplier audits and close corrective actions.
• Assist preparation for Notified Body and regulatory audits or inspections.
• Coordinate CAPAs from initiation through root-cause investigation and closure.
• Perform root-cause analysis and challenge inadequate investigations or corrective actions.
• Monitor CAPA and nonconformity trends and escalate systemic issues.
• Support complaint intake, investigation and trending with relevant technical functions.
• Collaborate with Regulatory Affairs and Vigilance to ensure timely escalation of complaints.

Conhecimentos

ISO 13485

EU MDR

Internal Audits

Supplier Audits

CAPA

Root-Cause Analysis

Nonconformities/ Deviations

Complaint Handling

Regulatory Affairs Interface

Analytical Thinking

Documentation/Report-Writing

Stakeholder Management

English Proficiency

German Language

Formação académica

University degree in engineering, medical technology, natural sciences or life sciences

Descrição da oferta de emprego

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.