Project Coordinator III
Medtronic
- Gurgaon, Haryana
- Permanent
- Full-time
- Ensure personal understanding of all quality policy/system items that are personally applicable. Follow all work/quality procedures to ensure quality system compliance and high-quality work.
- Provide to the regions the guidance according to the correct handling of the process.
- Ensuring alignment with QA SSC FCA specialist about actions to be done with the stakeholders responsible for FCA execution.
- Manage follow-ups to obtain missing information to close the request from OU, according to consignee list.
- Previous experience supporting quality system audits.
- Strong technical writing and documentation review skills.
- Strong critical thinking and analytical skills.
- Independent compliance decision maker (based on knowledge of regulations, available relevant information, alternatives, risk).
- Good understanding of the Medical Device Regulations and the Food and Drugs Acts as pertinent to the position. Working knowledge of ISO 13485, and Medtronic policies and procedures.
- Influence management skills: ability to work constructively across all functions of the organization and build relationships
- Experience writing and reviewing of technical documentation.