We are seeking an experienced Quality Assurance Specialist to maintain compliance, drive continuous improvement, and ensuring high-quality standards across processes and systems. You will work in a dynamic environment that values precision, collaboration, and innovation. Are you a QA professional, with good knowledge about GMP and medical devices, looking for your next challenge? Apply now!
Job DescriptionAs a Quality Assurance Specialist, you will oversee the quality management system and manage change control processes. You will ensure that all procedures and documentation comply with regulatory requirements and internal standards. The role involves supporting engineering and R&D projects by providing quality input, preparing validation plans, and conducting risk assessments. Additionally, you will analyze performance trends, manage non-conformities, and lead corrective and preventive actions to enhance operational excellence.
Responsibilities- Administer the change control process and maintain documentation within the quality system.
- Develop and approve procedures, work instructions, and specifications.
- Monitor performance trends and report improvement opportunities to management.
- Investigate and resolve deviations and CAPAs.
- Provide quality assurance support for engineering projects, including validation documentation.
- Conduct risk analyses and prepare risk management plans for R&D initiatives.
- Audit design files and participate in design reviews.
- Analyze production data to identify sources of variation and implement improvements.
- Bachelor's degree or equivalent experience (4-6 years), preferably in pharmaceutical or medical device industries.
- Strong knowledge of GMP, ISO 13485, ISO 14971, QSR CFR 820, and MDR regulations.
- Experience with quality management systems and validation processes.
- Proficiency in MS Office and familiarity with statistical and quality improvement techniques.
- Excellent communication skills in English; Dutch proficiency is an advantage.
- Flexible, detail-oriented, and able to work independently as well as in a team.
- Region: Leiden area (Netherlands)
- Full-time on-site position in a modern GMP manufacturing environment
- Salary: between €5000 and €7000 gross monthly, based on experience and qualifications
- Contract type: temporary assignment through Oxford Global Resources with potential for extension
- A collaborative culture focused on quality and continuous improvement.
- Vacancy number: 26888
€5000 - €7000 monthly