Senior Quality Assurance Officer

Are you ready to take on a pivotal role that combines strategic oversight, analytical rigor, and global impact? Join our innovative team and help revolutionize over-the-counter (OTC) medical devices designed to treat skin, throat, nose, and other common ailments. From pioneering cutting-edge products to navigating complex global regulatory landscapes, we bring ideas to life and ensure they reach markets worldwide.

We are looking for a Quality Assurance Manager with a strong background in pharmaceuticals or medical devices, an eye for detail, and a passion for quality systems. If you're ready to lead QA in a dynamic, impact-driven environment, this is your opportunity!

What You’ll Love About This Role:

• Impact: Shape the quality strategy for products that redefine self-care globally.
• Versatility: Tackle a range of tasks from design transfer to regulatory compliance and production oversight.
• Growth: Step into a leadership role with autonomy and the chance to expand our QA/RA function.
• Teamwork: Collaborate closely within a vibrant, multidisciplinary team passionate about innovation.

What We’re Looking For:

Experience:

• Minimum of 2–3 years in Quality Assurance within medical devices, pharmaceuticals, or IVDs.
• At least 1 year of experience in a QA management or leadership role.

Knowledge:

• Solid understanding of ISO 9001 and ISO 13485.
• Familiarity with EU MDR (Regulation 2017/745), ISO 14971, and 21 CFR Part 820.
• Bonus: Knowledge of Clinical Evaluation Standards (MEDDEV 2.7.1 Rev 4) and Clinical Investigations (ISO 14155).

Education:

• MSc in Pharmacology, Chemistry, Biology, Quality Management, or a related field.

Skills:

• Strong organizational and digital process management skills.
• Proactive, solution-focused mindset with keen attention to detail.
• Fluency in Dutch and English (written and spoken).

Core Responsibilities:

• Oversee and continuously improve our ISO- and MDR-certified Quality Management System (QMS).
• Ensure compliance with EU MDR, ISO 13485, and other relevant international standards.
• Develop and maintain quality documentation (SOPs, WIs, manuals).
• Lead CAPA, complaint handling, PMS, vigilance, and risk management activities.
• Coordinate Management Reviews and internal/external audits (including CMOs).
• Support design transfers and provide QA input to R&D and production teams.
• Analyze quality metrics to identify opportunities for improvement.
• Interface with regulatory and notified bodies as required.

What Drives Us:

• Pushing Boundaries: We thrive on bold thinking and creative solutions.
• Reliability: We build trust—through our products and our people.
• Excellence Through Dedication: Good enough is never enough.
• Collaboration: A close-knit, transparent culture where every voice matters.

Ready to make an impact? Apply now to join our team and help us redefine the future of self-care!