Your area of responsibility
Quality Management System (QMS)
* Author and revise Standard Operating Procedures (SOPs) and quality system documentation in line with ISO 13485 and EU MDR 2017/745 requirements.
* Conduct GAP analyses of the QMS to identify compliance gaps and support continuous improvement activities.
* Work closely with cross-functional teams to support the consistent implementation of QMS processes throughout the organization.
CAPA & Non-Conformance Management
* Manage and coordinate Corrective and Preventive Actions (CAPAs), ensuring timely progression and closure.
* Support the closure of Non-Conformances (NCs) following internal audits, gathering evidence and completing the required quality records.
* Perform root cause analysis and propose corrective and preventive measures.
Audit Support
* Prepare and organise quality documentation and records ahead of and during internal audit days.
* Track open audit findings and NC closure activities, coordinating with relevant departments to meet agreed timelines.
* Contribute to maintaining ongoing audit readiness across all QMS areas.
Product Quality Control – Class IIa Medical Devices
* Carry out daily quality checks and documentation review to support the release of Class IIa medical device products.
* Review and prepare Pre-Shipment Lot Quality Reports, verifying product conformance against specifications and applicable quality standards.
* Apply global quality standards consistently across all product release activities.
Medical Product Artwork Review
* Review medical device product artworks — including labels, Instructions for Use (IFUs), and packaging — for compliance with quality and regulatory requirements.
* Coordinate artwork-related change controls with relevant internal teams.
Supplier Quality Management
* Maintain and regularly update the Approved Supplier List (ASL), with particular focus on critical suppliers.
* Support supplier qualification and ongoing performance monitoring activities.
* Collaborate with Procurement and Supply Chain to identify, escalate, and resolve supplier quality issues.
What distinguishes you
* Bachelor's degree in Quality Management, Engineering, Biotechnology, or a related field. Alternatively, possess equivalent technical education in (Medical) Technology or Natural Sciences.
* Minimum 2 years of experience in Quality Assurance and/or Quality Control within the Medical Device industry.
* Solid knowledge of ISO 13485 and EU MDR 2017/745.
* Proven experience in authoring SOPs and maintaining QMS documentation.
* Hands-on experience with CAPA management and non-conformance handling.
* Experience supporting internal audit activities, including documentation preparation and record management.
* Familiarity with Class IIa medical device product release and quality control processes.
* Experience maintaining Approved Supplier Lists and conducting supplier quality reviews.
* Knowledge of pre-shipment inspection and lot release processes.
* Familiarity with global quality standards such as 21 CFR Part 820 or MDSAP.
* Quality certification (e.g., CQE, ISO 13485 Internal Auditor) is a plus.
* Proficiency in MS Office applications, databases, and document management systems.
* Exceptional analytical skills and problem-solving abilities to address complex quality-related challenges effectively.
* Strong team-oriented work approach with excellent communication skills, both verbal and written.
* Fluent in both German and English languages, with proficiency in technical terminology and documentation.