Requirements: English
Company: Barrington James
Region: Amsterdam , North Holland
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 Youll 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 Were Looking For:
Experience:
- Minimum of 23 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 trustthrough 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!