Quality Assurance Specialist, Stuttgart, Germany

OPEN POSITION: Quality Assurance Specialist / SENIOR SPECIALIST

VSY Biotechnology GmbH is a globally active, innovation-driven biotechnology company specializing in ophthalmology and viscoelastic medical solutions. With a strong commitment to research, sustainability, and regulatory excellence, we strive to improve patient outcomes through advanced technologies and high-quality products.

We are looking for a Quality Assurance Specialist to join our dynamic team. The ideal candidate will play a key role in maintaining and enhancing our quality systems, ensuring compliance with international standards and supporting continuous improvement initiatives.

Responsibilities:
•Managing and improving the overall quality management system (QMS) according to relevant standards and requirements.
•Ensuring compliance with ISO 9001 standards and supporting the implementation of ISO 13485 (training for ISO 13485 will be provided if necessary).
•Conducting audits and audit support, including preparation and follow-up of internal and external audits.
•Overseeing supplier qualification processes and conducting supplier visits to ensure quality standards are met.
•Managing and documenting vigilance incidents and coordinating the appropriate actions and reporting.
•Responsible for product release, ensuring that products meet all quality requirements and regulatory standards before release to the market.
•Responsible for document management within the QMS, including the creation and maintenance of quality documents and policies.
•Ensuring continuous improvement of the quality management system through regular evaluations and adjustments.
•Conducting and supporting internal audits to ensure the effectiveness of the QMS and compliance with internal and external standards.
•Ensuring compliance with relevant regulatory requirements, industry standards, and internal policies.

Qualifications:
•Completed education or degree in Quality Management, Engineering, or a related field.
•Experience in quality management, ideally in the medical device industry or another regulated environment.
•In-depth knowledge of ISO 9001; experience with ISO 13485 is an advantage but not required (training will be provided).
•Experience as an auditor or in conducting audits (internal/external).
•Knowledge and experience in managing vigilance incidents.
•Strong experience in ensuring compliance with industry regulations and internal quality standards.
•Experience with product release processes and ensuring compliance with regulatory requirements.
•Strong communication skills and a solution-oriented mindset.
•Independent, structured, and reliable work style.
•Good command of English is advantageous.

#J-18808-Ljbffr