Quality Assurance Manager

Barrington James

Amsterdam

On-site

USD 58,187 - 104,736

Full time

14 days+

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Job summary

An innovative firm is seeking a Quality Assurance Manager to lead QA efforts in developing cutting-edge OTC medical devices. This pivotal role involves enhancing quality systems, ensuring compliance with international standards, and collaborating with a passionate team dedicated to redefining self-care. With a focus on strategic oversight and analytical rigor, you will have the opportunity to shape quality strategies that impact global markets. If you have a strong background in pharmaceuticals or medical devices and are ready to make a difference, this role is perfect for you!

Qualifications

2-3 years in Quality Assurance in medical devices or pharmaceuticals.
1 year in a QA management or leadership role.

Responsibilities

Oversee and improve the Quality Management System (QMS).
Ensure compliance with EU MDR and ISO 13485 standards.
Lead CAPA and risk management activities.

Skills

Organizational Skills

Digital Process Management

Attention to Detail

Proactive Mindset

Fluency in Dutch

Fluency in English

Education

MSc in Pharmacology

MSc in Chemistry

MSc in Biology

MSc in Quality Management

Tools

ISO 9001

ISO 13485

EU MDR

ISO 14971

21 CFR Part 820

Job description

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: