The Company
A leading organization dedicated to advancing healthcare through precision manufacturing and innovation. Committed to maintaining the highest standards of quality, safety, and compliance across all processes and products.

Role Description
As a Quality Assurance Specialist, you are responsible for maintaining and continuously improving quality systems to ensure full regulatory compliance and product integrity. You will provide quality oversight and support to Engineering, R&D, and Quality Operations, contributing to robust processes, compliant systems, and high-quality products.

Responsibilities
- Manage change control activities and maintain controlled documentation.
- Ensure compliance with quality standards, GMP, and applicable regulatory requirements.
- Handle non-conformities, deviations, and lead CAPA activities.
- Review and approve changes to products, processes, and systems.
- Support engineering and R&D projects, including validation and risk management activities.
- Contribute to continuous improvement through analysis of production data and regulatory updates.

Requirements
- Bachelor’s degree or equivalent experience in a relevant discipline.
- 4â€"6 years of relevant experience, preferably within pharmaceutical or medical device industries.
- Strong knowledge of GMP, MDD/MDR, QSR (21 CFR 820), ISO 13485, and ISO 14971.
- Hands-on experience with Quality Management Systems (QMS) and validation of systems and processes.
- Proficiency in MS Office and familiarity with statistical and quality improvement methodologies.
- Strong communication skills; flexible, detail-oriented, and able to work independently as well as collaboratively.
- Fluency in English is required; knowledge of Dutch is an advantage.

Other Information
If you are interested and want to apply, please submit your application via the apply button below and contact me.
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