Company
A leading organization in the healthcare and medical device sector, dedicated to delivering innovative and high-quality products. The company values continuous improvement, regulatory compliance, and a strong commitment to safety and quality standards.

Job Description
As a Senior Quality Assurance Specialist, you will be overseeing quality systems, ensuring compliance with industry regulations, and supporting engineering and R&D projects to maintain the highest quality standards throughout product development and manufacturing processes.

Responsibilities

• Manage the change control program, ensuring local procedures and specifications are up to date within the document control system.
• Lead efforts to comply with company policies, procedures, quality standards, and relevant safety and environmental regulations.
• Develop and update operating procedures, collaborating with team members as needed.
• Monitor performance trends, identify areas for improvement, and report findings to management and cross-functional teams.
• Oversee non-conformity management and support investigation and resolution of CAPAs (Corrective and Preventive Actions).
• Review, advise on, and approve changes to products, processes, and systems according to established procedures.
• Ensure continuous improvement of quality practices, responding to regulatory changes and data-driven insights.
• Support engineering projects by providing quality assurance input, creating validation plans, and assisting with documentation for equipment and process validation.
• Collaborate with R&D to perform risk analyses, develop risk management plans, and contribute to design reviews and audits.
• Support quality operations by addressing production non-conformities, managing deviations, and analyzing reject data to drive continuous improvement.
• Maintain and support the quality management system in line with GMP, ISO, and other relevant standards.

Requirements

• Bachelor's degree or equivalent work experience in a related field.
• 4-6 years of relevant experience, preferably within the pharmaceutical or medical device industries.
• Strong knowledge of GMP, ISO 13485, ISO 14971, QSR CFR 820, or MDD/MDR regulations.
• Experience with quality assurance systems and validation of technical systems and processes.
• Proficiency in MS Office and data analysis techniques.
• Excellent communication skills in English; proficiency in Dutch is a plus.

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

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