QA/RA Engineer

Are you enthusiastic about contributing to the development, production, and market launch of medical devices? Do you possess a background in Quality Control, Quality Assurance, or Regulatory Affairs? If ensuring quality is your focus, my client is seeking a skilled QA/RA Engineer like you to join their team.

In close collaboration with the QA/RA Manager and Operational Manager, you will play a pivotal role.

Key Responsibilities:

Quality Management System (QMS):

• Maintain documentation aligned with ISO-13485 and medical regulations (MDR).
• Generate periodic reports, including radiation safety, audits, CAPA.
• Conduct employee training sessions.
• Drive improvement proposals.
• Oversee both internal and external audits.

Technical Documentation and Products:

• Establish and manage technical files.
• Prepare accurate product documents and labels.
• Perform risk assessments for products.
• Contribute to project discussions.
• Offer project support through CAD and documentation.
• Ensure compliance with radiation safety protocols.

Location: Primarily based in Veenendaal, with clients spanning hospitals and healthcare institutions across Europe and Africa.

Requirements:

• Minimum MBO/HBO degree in a technical, paramedical, or quality-related field, coupled with relevant experience.
• Familiarity with ISO 13485 and MDR.
• Proficiency in managing Quality Management Systems.
• Ability to drive change and foster consensus.
• Demonstrated commitment to quality, coupled with critical and adaptable work ethics.
• Preferred: Knowledge of project management, experience with CAD systems.
• Fluent in both Dutch and English, written and spoken.
• Preferred residence within a 30 km radius of Veenendaal.

What You Can Expect:

• A dynamic role within a financially stable organization.
• Provided laptop and phone.
• Engage in an international work environment.
• Play an active role in the medical sector.
• Join my client's dedicated and engaged team.
• Access opportunities for personal and professional growth.

About My Client:

My client is a leading player in the medical technology sector, known for delivering high-quality medical products to hospitals, clinics, veterinary clinics, and dentists. With a strong history spanning over 70 years, their expertise in healthcare processes, modalities, and IT empowers them to provide comprehensive solutions to their clients. If this resonates with you, join my client's impactful team today!