We are seeking a Quality Assurance Specialist to support and manage the Quality Management System (QMS) across Operations, Engineering, and R&D. In this role, you will ensure compliance with global regulatory requirements, drive continuous improvement initiatives, and provide quality leadership throughout the product and process lifecycle.
In this role, you are the guardian of the Quality Management System, ensuring that quality, compliance, and continuous improvement are embedded in everything the organization does. You administer the change control program and maintain local procedures and specifications within the document control system, ensuring that all documentation remains accurate, current, and compliant. You lead adherence to company policies, quality standards, and applicable safety and environmental regulations, acting as a trusted quality partner across the business.
You take ownership of managing non‑conformities, deviations, and internal quality escalations, ensuring issues are investigated thoroughly and resolved effectively. Corrective and Preventive Actions (CAPAs) are driven to timely and sustainable closure, with a strong focus on root cause analysis and long‑term improvement. As part of your quality oversight responsibilities, you review, advise on, and approve changes to products, processes, and systems, ensuring alignment with established procedures and regulatory expectations. You also approve QMS‑related procedures and work instructions, safeguarding the integrity of the quality system.
Continuous improvement is a core part of your mission. You actively monitor regulatory developments, performance trends, deviations, and other data‑driven insights to strengthen the quality system and ensure ongoing compliance. You contribute by writing new operating procedures and supporting colleagues in updating existing documentation, ensuring clarity, consistency, and usability. By analyzing quality and performance data, you identify significant trends and communicate meaningful insights to management and cross‑functional teams, helping drive informed decision‑making and process optimization.
In support of engineering projects, you provide quality assurance guidance throughout the implementation of new processes and equipment. You ensure that validation requirements are clearly defined and met by supporting the creation, review, and approval of equipment and process validation documentation, including validation plans and reports that meet regulatory expectations.
You also play a key role in supporting R&D activities, ensuring quality and regulatory requirements are integrated from early product and process development stages. You perform risk analyses and develop Risk Management Plans and Reports in accordance with ISO 14971, review and prepare validation documentation, audit Design History Files, and actively participate in Design Reviews to ensure compliance, robustness, and patient safety.
Within Quality Operations, you work closely with production teams to address non‑conformities and manage internal escalations. You guide and assess planned deviations, review and approve changes to production processes, and analyze reject and defect data to identify opportunities for continuous improvement. Through data‑driven analysis and cross‑functional collaboration, you help reduce variation, improve process performance, and strengthen overall product quality.
Functie-eisen
- Bachelor’s or University Degree, or equivalent work experience.
- 4–6 years of relevant experience, preferably within the pharmaceutical or medical device industry.
- Strong knowledge of GMP, MDD/MDR, 21 CFR Part 820 (QSR), ISO 13485, and ISO 14971.
- Experience with Quality Management Systems (QMS).
- Knowledge of validation of technical systems and manufacturing processes.
- Solid understanding of statistics and quality improvement methodologies.
- Proficient in MS Office applications.
Competenties
- Strong communication and stakeholder‑management skills.
- Flexible, accurate, and detail‑oriented working style.
- Ability to work independently as well as collaboratively in cross‑functional teams.
- Excellent command of English; proficiency in Dutch is required.
Arbeidsvoorwaarden
- Discount on the collective health insurance scheme via Zilveren Kruis
- Access to the YACHT network of companies and industry specialists
- A favorable pension scheme (STIPP)
- 8 % holiday allowance
- Good travel allowance of €0.23 per km up to 26 km one way
- Training budget provided by Yacht: €3,500 per year
- A one-time home office allowance of €750
- Soft skills coaching
Bedrijfsinformatie
Imagine your next project contributing to the next healthcare breakthrough at Johnson & Johnson Vision, helping more people around the world preserve and restore sight.
Establishes and maintains quality assurance programs, procedures and controls, ensuring that performance parameters of both the products and quality system elements are continually measured to drive improvement initiatives.
Randstad Professional is dé organisatie van en voor professionals. Wij verbinden professionals en organisaties die het verschil maken. Ons doel is het optimale resultaat: jou als professional uitdagend werk bieden waarin jij de organisatie van onze opdrachtgevers blijvend kunt verbeteren. Wil jij samen met collega’s het verschil maken binnen toonaangevende (internationale) organisaties?
Werkgeverschap van Randstad Professional
Het is onze missie om jou het juiste klimaat te kunnen bieden waarin jij jezelf verder kunt ontwikkelen. Wij verwachten vanuit jouw kant dat jij het maximale uit je opdracht haalt, om je daarbij te helpen stellen we samen een project plan met je op zodat jij het beste presteert.
Inclusiviteit en diversiteit
Uiteraard staat deze vacature open voor iedereen die zich hierin herkent. We geloven dat diverse teams van belang zijn voor ons als lerende organisatie, die voorop wil blijven lopen in de wereld van werk. Want juist verschillen tussen mensen zorgen voor groei. Van collega's, klanten, kandidaten en daarmee van Yacht. Heb jij een uniek talent? We ontmoeten je graag.