Sr. Quality Engineer
Introduction
We are seeking a Senior Quality Engineer for an ambitious and innovative medical device scale-up committed to improving diabetes care through advanced insulin pump technology. You’ll be joining a highly diverse and international team in a role that offers the opportunity to connect with colleagues across the globe and expand your network. Utrecht, a vibrant international city, provides a dynamic lifestyle with endless opportunities for new connections and experiences, both socially and professionally. You’ll thrive in this energetic setting that promotes learning, innovation, and fun!
As a Senior Quality Engineer, you will be responsible for driving quality improvements and process validation for new equipment and production lines. You’ll play a vital role in the successful transition of manufacturing processes to international suppliers. In collaboration with cross-functional teams, including Manufacturing, Quality, R&D, and Regulatory Affairs, you’ll ensure that products meet the highest quality standards throughout their lifecycle.
As the company expands internationally, they are launching a new generation of products and increasing production with the help of overseas suppliers. This role plays a pivotal part in the New Product Introduction (NPI) process, with a focus on ensuring high-quality standards through process validation, documentation, and inspection activities.
Responsibilities
• Lead and guide process validation activities for new equipment, production lines, and test methods.
• Develop, review, and approve validation documentation, including R&D documents, leveraging statistical knowledge and quality control principles.
• Oversee inspection processes, ensuring accurate and timely documentation updates.
• Collaborate with Manufacturing, Quality, and R&D teams to implement quality controls and improvements.
• Support the transition of production lines to overseas suppliers and ensure all validations are in place.
• Participate in risk management sessions and audits, and lead activities related to equipment verification and validation.
• Conduct root cause analysis and implement corrective and preventive actions (CAPA) for non-conformances.
• Support internal, supplier, and external audits, ensuring compliance with ISO 13485, MDR, and 21 CFR 820.
• Deliver quality-related training and guidance to cross-functional teams.
• Continuously challenge and improve NPI processes, focusing on process validation and quality assurance.
Ideal Candidate
The ideal candidate is a proactive and analytical problem solver with a hands-on mentality, capable of working independently and as part of a team. You are experienced in leading process validations and managing a high volume of documentation in a fast-paced, dynamic environment.
Qualifications & Experience
• Bachelor’s degree in Quality, Engineering, Biomedical Engineering, or Health Sciences (or equivalent experience).
• 5+ years of experience in Quality Engineering, with a focus on process validation and quality control.
• Strong knowledge of ISO 13485, MDR, and 21 CFR 820.
• Experience with statistical techniques, process validation, and test method validation.
• Familiarity with cleanroom environments and sterilization processes is a plus.
• Fluent in English, with strong problem-solving, organizational, and project management skills.
• Experience working in start-ups or scale-ups is desirable.
What’s Offered
• Competitive salary
• Relocation package
• Full-time position (40 hours per week) with flexible hours
• Contributions to commuting costs, on-site parking, and gym membership discounts.
Location Benefits
Utrecht offers a vibrant atmosphere with a perfect blend of historical charm and modern amenities. Located 48km south of Amsterdam, the city provides easy access to major hubs while maintaining a great work-life balance, making it an ideal place to advance your career.
If you’re a Senior Quality Engineer with a passion for process validation and a desire to make a meaningful impact in the medical device industry, we encourage you to apply!