Jr. QA Officer - great development environment

Job Description: Junior QA Officer
Location: Amsterdam Region
Type: Full-time (Minimum 3 days per week in-office)
Language Requirements: English (fluent) and conversational Dutch

About Us
We are an innovative medical device start-up in the Amsterdam region, backed by successful investment rounds and poised for exponential growth. Our mission is to develop cutting-edge medical technologies that improve patient outcomes and set new standards in healthcare. To support our expanding operations, we are seeking a proactive and detail-oriented Junior QA Officer to join our team.

Role Overview
As a Junior QA Officer, you will play a pivotal role in ensuring our Quality Management System (QMS) aligns with regulatory standards such as ISO 13485 and MDR. You will work closely with cross-functional teams to drive continuous improvement, address non-conformities, and ensure compliance. This position offers the opportunity to contribute to building and refining processes in a dynamic and collaborative environment.

Key Responsibilities

• Maintain and improve the Quality Management System (QMS) in compliance with ISO 13485 and MDR.
• Manage non-conformities, Corrective and Preventive Actions (CAPA), and drive root cause analysis.
• Support the implementation of eQMS tools and ensure proper documentation.
• Participate in or conduct internal audits (if experienced).
• Develop and refine quality-related processes and procedures, ensuring compliance with regulatory requirements.
• Collaborate with cross-functional teams to create and update validation protocols and reports (big pre).
• Drive continuous improvement initiatives across the organization.
• Support the preparation and hosting of external audits.
• Act as a proactive communicator, ensuring quality and compliance considerations are addressed in all projects.

Qualifications

• Bachelor's degree in a related field (e.g., Biomedical Engineering, Life Sciences, Quality Management).
• At least 1 year of experience in the medical device industry.
• Strong knowledge of ISO 13485, MDR, CAPA, and handling non-conformities.
• Experience with QMS or eQMS implementation and maintenance.
• Familiarity with validation report writing (big pre).
• Proactive, independent, and detail-oriented work style.
• Strong communication skills in English and conversational Dutch.
• Willingness to work at least 3 days per week from the office.

What We Offer

• A collaborative and dynamic start-up environment with room to grow and make an impact.
• Competitive salary and benefits package.
• Opportunities for professional development and training.
• A mission-driven culture focused on innovation and improving lives.

If you are passionate about quality, enjoy working in a fast-paced environment, and want to be part of a team that is shaping the future of healthcare, we would love to hear from you!

How to Apply
Please submit your resume and cover letter and highlighting your relevant experience and motivation for the role.

We look forward to welcoming a proactive and dedicated Junior QA Officer to our team!