Overview
Senior Quality Assurance Manager Jobs in Utrecht, Netherlands at Panda International
Title: Senior Quality Assurance Manager
Company: Panda International
Location: Utrecht, Netherlands
Role: Senior QA Manager – Design Controls
We are partnering with a global Medical Device company seeking a QA Manager specializing in Design Controls. This is a strategic leadership opportunity to ensure compliance in product development, risk management, and quality assurance processes while driving cross-functional
collaboration to bring high-quality medical devices to market.
Location: Utrecht – Hybrid
Scope: Design Quality & Compliance
The Role
As a QA Manager, you will oversee design control activities, risk management, and regulatory compliance for finished medical devices. You will lead quality assurance initiatives, mentor a QA team, and drive process improvements to enhance efficiency and compliance with ISO 13485, MDR 2017/745, PPE, and other applicable regulations.
Key Responsibilities
Oversee design control activities, ensuring compliance with ISO 13485, MDR, PPE, and ISO 14971 risk management, integrating them into product development.
Manage design history files (DHFs) and ensure robust documentation across design reviews, verification, validation, and design transfer.
Supervise product testing and ensure compliance with EU regulatory requirements.
Lead a team of 7 direct reports (remote team), mainly QA engineers. Lead, mentor, and develop the QA team, fostering a culture of quality and driving continuous improvement initiatives.
Develop and track quality metrics, reporting to senior management while ensuring alignment with corporate and regulatory standards.
Support internal/external audits, CAPA management, and regulatory compliance, collaborating with Regulatory Affairs on EU requirements.
Investigate defective product trends and customer complaints, coordinating supplier quality management and decision-making on deviations.
Provide QA support for EU market tenders and product management.
Qualifications & Experience
Degree in Life Sciences (Biology, Chemistry) or Engineering with 6+ years of experience in the Medical Device industry.
Strong knowledge of ISO 13485, MDR 2017/745, and related regulations.
Expertise in design controls, risk management, and regulatory compliance.
Track record in leading and developing a QA team.
Strong leadership, communication, and problem-solving skills.
Ability to manage complex quality operations in a fast-paced environment.
Fluent in English; French is a plus.
Frequent travel to France is required (approx. 1 x per month).
Why Join?
Be part of a long-established Medical Device company that is growing rapidly and has a global expsoure. The company specializes in Class I and Class II sterilized and non-sterilized surgical products, offering an opportunity to lead and shape quality assurance in a dynamic and innovative sector.
How to Apply
If you are an experienced QA Manager with expertise in design controls and regulatory compliance within MedTech, Life Sciences, or Pharmaceuticals, we’d love to hear from you!
Apply now or contact Aimee Brenner at [email protected] for more information.
