(Junior) Quality Assurance Specialist (all genders)

medisana GmbH

(Junior) Quality Assurance Specialist (all genders)

Neuss – Full‑time permanent employment

Responsibilities

• 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.

Qualifications

• 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.

Benefits

• Committed team with short decision‑making processes.
• Permanent employment contract.
• Flexible working hours.
• 30 days annual leave.
• Hybrid work – one remote day per week.
• Wide range of training opportunities – free access to GoodHabitz for all employees.
• HRmony benefit.
• Employee discounts on our full product range.
• Corporate Benefits – exclusive discounts and special offers for employees.
• Bike leasing program.
• Modern offices with advanced technology.
• Structured training programs.
• Challenging and responsible job in a forward‑looking industry.
• Excellent transport connections by car, bus, or train.

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 competitive 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.