Senior Quality Assurance Specialist
We are seeking an experienced Senior Quality Assurance Specialist to lead the quality department in ensuring our products meet stringent quality and safety standards.
Key Responsibilities:
* Quality Management System Implementation: Collaborate with cross-functional teams to implement and maintain a robust quality management system aligning with ISO 13485, MDD 93/42/EEC, and MDR 2017/745 requirements.
* Management Representative Support: Provide operational support to the management representative as needed.
* Product Launch and Change Control: Ensure seamless product launches and change controls adhere to ISO 13485, MDD 93/42/EEC, and MDR 2017/745 guidelines.
Requirements:
* At least 3 years of experience in a Quality/Validation role within Medical Device or Pharmaceutical environments.
* A degree in Engineering, Manufacturing, or Quality with a focus on Medical Devices/Biomedical.
* Bachelor's degree in Science, Engineering, or Quality-related disciplines.