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(Junior) Quality Assurance Specialist (all genders)
medisana GmbH
Neuss
Vollzeit
Gesundheitsangebote
Flexible Arbeitszeiten
Jobrad
Neu:
27.05.2026
Ref-Nr: SDE-95555
Jetzt bewerben
(Junior) Quality Assurance Specialist (all genders)
Jetzt bewerben
Jetzt bewerben
medisana GmbH
(Junior) Quality Assurance Specialist (all genders)
Neuss
Vollzeit Festanstellung
medisana GmbH is one of the leading specialists in the home health care market. As part of the OGAWA Group, one of the world's leading manufacturers of massage products, we are represented in more than 40 countries with various brands.
We are developing, promoting and distributing products in the categories of mobile health, health control, wellness, body care, therapy and healthy home for health-conscious consumers worldwide.
You want to grow professionally, take responsibility, and contribute to the quality of innovative medical and wellness products. Then join our Quality Management & Regulatory Affairs team in Neuss and help us make a real impact as our
(Junior) Quality Assurance Specialist (all genders)
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 relev...
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