(Junior) Quality Assurance Specialist (all genders)

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) 

• Committed team with short decision making processes - we look forward to your input! 
• Permanent employment contract - long-term cooperation is important to us 
• Flexible working hours - We manage both: private and professional life 
• 30 days annual leave - plenty of time to recharge your batteries 
• 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 
• Beautiful offices and modern technology - atmosphere combined with efficiency 
• Structured training - We take the time for you! 
• A challenging and responsible job in a forward-looking industry - variety guaranteed 
• Very good transport connections - by car, bus or train to work

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. 

• 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. 

Motivated and committed employees are a prerequisite for the success of our company. To this end, we offer you a varied job in a collegial working environment with a salary range. Innovative ideas are the cornerstone of our success as a leading provider of Connected Health products. You can expect interesting and challenging tasks in fields that influence our future, as well as a motivated and friendly team. Do you want to be successful with us? Then send us your application including CV and your availability to: Medisana GmbH, Human Resources 

medisana GmbH | Personalabteilung | Carl-Schurz-Straße 2 | 41460 Neuss | www.medisana.de 

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