(Junior) Quality Assurance Specialist (all genders)

(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.

What you can look forward to

• 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

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, elevate, 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.