Junior) Quality Assurance Specialist (all genders)
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. Junior) Quality Assurance Specialist (all genders) Your area of responsibility
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.
Support the closure of Non-Conformances (NCs) following internal audits, gathering evidence and completing the required quality records.
Audit Support
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.
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.
Support supplier qualification and ongoing performance monitoring activities.
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.
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.
Familiarity with global quality standards such as 21 CFR Part 820 or MDSAP.
Proficiency in MS Office applications, databases, and document management systems.
Fluent in both German and English languages, with proficiency in technical terminology and documentation.
Permanent employment contract - long-term cooperation is important to us
~ Flexible working hours - We manage both: private and professional life
~Hybrid work- One remote day per week for added flexibility.
~ Wide range of training opportunities – free access to GoodHabitz for all employees
~ HRmony - The benefit that brings joy
~ Attractive employee discounts on our full product range
~ Corporate Benefits – Exclusive discounts and special offers for employees
~ Bike leasing - We support a health-promoting and environmentally conscious alternative to the car
~ Very good transport connections - by car, bus or train to work
To this end, we offer you a varied job in a collegial working environment with a salary range.