Vacancy: Quality Manager (QA Manager) – Medical Devices IVF products

📍 Location: Vreeland, The Netherlands

📅 Employment Type: Full-time (minimum 32 hours)

💼 Industry: Medical Devices / Quality Assurance

About Us

BIRR BioSciences b.v. is a family owned company operating in the field of fertility. BIRR focusses on the development and manufacturing of products used to fulfill the dream of many patients. BIRR is a dynamic young company in the scale-up phase.

Are you a driven Quality Manager with experience in the medical device industry? Do you want to play a key role in ensuring the highest quality standards within an innovative and dynamic company? Then we are looking for you!

At BIRR BioSciences b.v., we are committed to delivering safe and high-quality medical devices for fertility treatments. We continuously strive for improvement and seek a professional who can maintain and continuously improve our ISO 13485 certified Quality Management System (QMS) and ensure compliance with strict industry regulations.

You will have a close collaboration with other colleagues within the QA/RA team taking care of quality aspects as well as the technical documentation of the medical device families.

Your Role as Quality Manager

As a QA Manager, you will have overall responsibility for the Quality Management System, acting as the Management Representative. You will, in collaboration with the QA/RA BIRR-team, be responsible for ensuring compliance with quality standards and regulations, including the Medical Device Regulation (MDR). You will play a vital role in quality process optimization and implementation of a quality mindset throughout the organization. You will act as a key point of contact between the quality department and the broader organization.

Key Responsibilities:

✔ Manage and implement quality standards, focusing on MDR and ISO 13485 and MDR.

✔ Support and guide internal and external audits, ensuring compliance.

✔ Handle complaints and non-conformities, assisting the back-office team in follow-ups and resolutions.

✔ Oversee document and record management within our electronic QMS (D4).

✔ Monitor quality control activities and supplier compliance.

✔ Review and approve batch documentation and develop batch certificates.

✔ Promote a quality-focused culture through awareness and training initiatives.

What You Bring:

✔ Education: Bachelor's degree (HBO level), preferably in a relevant field.

✔ Experience: At least 2 years in the medical device industry.

✔ Knowledge: QMS preferably ISO 13485, MDR, and risk-based decision-making.

✔ Skills:

Strong communication and teamwork abilities.
Hands-on and execution capability.
Experience in project management and organizational change.
Analytical, detail-oriented, and quality-driven.

✔ Languages: Dutch & English.

What We Offer:

A challenging and responsible position in an innovative company.
Opportunities for professional growth and development.
A dynamic work environment with motivated colleagues.
Competitive salary and attractive benefits package.
Great can-do atmosphere and daily team lunch.

🔍 Apply Now!

Do you see yourself as our new Quality Manager? Send your CV and motivation letter to mark@birr.nl

We look forward to your application!

BIRR BioSciences

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