The Company
This company is a multinational corporation operating in the pharmaceutical industry. The company has evolved into one of the largest healthcare companies globally, with a diverse portfolio of products aimed at improving health and well-being. The Dutch facility mainly focusses on the production side of the company. They produce, test, and deliver innovative medicines for patients all around the world.
Role Description
The QA Engineer provides Quality Assurance support for mechanical and optical laboratory validation projects, ensuring compliance with industry standards and regulatory requirements such as ISO 13485. This role focuses on test method validation for Smartscope optical measuring devices used in the production of Intraocular Lenses, with responsibilities including drafting validation documentation, data analysis, and process improvement.
Responsibilities
-Ensure quality assurance within laboratory validation projects.
-Specify and improve test method validations.
-Draft and review test method validation plans, protocols, and reports.
-Ensure testing is performed consistently and accurately according to established protocols.
-Analyze test results using statistical tools to validate outcomes.
-Manage project timelines to align testing efforts with product development schedules.
-Advise, review, and approve changes in test methods and work instructions.
-Evaluate compliance with applicable laboratory standards and procedures.
-Act as the Validation Subject Matter Expert (SME) during projects.
-Provide training to team members on testing procedures, work instructions, and best practices.
Requirements
-2–4 years of relevant work experience, preferably in the pharmaceutical or medical device industry.
- Bachelor’s degree in Mechanical Engineering, Mechatronics, Physics, Engineering Science, or Bioengineering.
- GMP, MDD/MDR, QSR CFR 820, ISO 13485, ISO 14971.
-Quality assurance systems (QMS).
Other information
Apply to our vacancy for more information. looking forward to hearing from you!
54881
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