Quality Assurance Specialist
4 settimane fa
Job Title: Quality Assurance Specialist
Job Summary: We are seeking a highly skilled Quality Assurance Specialist to join our team at Silicon Biosystems. The successful candidate will be responsible for ensuring that our medical devices meet current regulatory requirements.
Key Responsibilities:
- Collaborate with R&D to apply the Design & Development process to our products.
- Manage the design change control process.
- Participate in risk management and support the preparation of risk analysis.
- Ensure the correct transfer of product from design phase to production phase.
- Prepare and maintain technical files and technical documentation.
- Draft quality assurance procedures.
- Implement applicable standards.
- Manage CAPA.
Requirements:
- Degree in Biology, Chemical, Biomedical Engineering, Electronic Engineering, or equivalent degrees.
- Excellent English knowledge (written and spoken).
- 2-5 years of experience in Quality Assurance and/or Regulatory Affairs or Research & Development or Verification & Validation in a company of Medical Devices.
- Experience with Quality Management System and with ISO 13485, ISO 14971.
About Us: Menarini Silicon Biosystems S.p.A. is committed to equal opportunity in the terms and conditions of employment for job applicants without regard to race, colour, religion, sex, sexual orientation, age, gender identity or gender expression, national origin.
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