QA/RA specialist

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Join a growing Life Science company within Medical Devices – Apply Today

Title: QA/RA Specialist

Reporting To: COO

Industry: Life Sciences -Medical Devices

Salary: upto €60,000/year

Location: Amsterdam

At Darwin Recruitment, we are proud to be partnered with a leading player in the Medical Device industry. They are committed to deliver inventive solutions to help elevate global patient care standards. Their mission is to transform the medical landscape by ensuring unwavering quality in their products and services. The mission of the business is to continually innovate in the world of patient care, allowing innovative products to be available globally.

Position Overview:

Within the position as a QA/RA Specialist Engineer, you will play a crucial role in ensuring the medical devices meet regulatory and quality standards. You will work in a cross functional company, collaborating with R&D, Supply Chain and Sales to ensure that new and existing products meet the requirements of the governing bodies.

Your Responsibilities:

Your responsibilities include but not limited to the following:

  • Develop, implement and maintain QMS processes in compliance with regulatory requirements (FDA, ISO13485, EU MDR etc)
  • Make sure that GMP, GLP and GCP are followed in the company
  • Conduct internal and external audits
  • Review and approve quality related documentation
  • Create, review and maintain clinical parts of the technical files
  • Support and review Risk Management Assessments

Your Qualifications:

  • BSc or MSc in Pharmaceutical Sciences, Biomedical Engineering, Chemistry, or a related field.
  • 3-5 years experience in a Quality Assurance related role in Pharmaceutical or Medical Device companies
  • Familiarity with QMS, GMP, GCP and GLP
  • Knowledge of FDA, ISO13485 or EU MDR
  • Experience within Audits is desirable but not essential
  • Some experience in medical/clinical documentation/writing

Darwin Recruitment is acting as an Employment Agency in relation to this vacancy.

Ryan Griffin

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