Quality Assurance Specialist

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.

• 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.

• 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.