Technical lead MDR, PFMEA

Job Summary

The Technical Lead will be responsible for leading the mdr, medical iso13485 process, Process Failure Mode Effect Analy(PFMEA) within the organization. They will oversee the technical aspects related to medical device reporting, ISO 13485 processes, and PFMEA.

Key Responsibilities

1. Provide technical leadership and guidance on mdr and medical device regulations.

2. Implement and maintain iso 13485 processes to ensure compliance.

3. Conduct process failure mode effect analysis (pfmea) to identify and mitigate risks in processes.

4. Collaborate with cross functional teams to drive continuous improvement in quality and regulatory processes.

5. Develop and update standard operating procedures (sops) related to mdr, medical devices, and pfmea.

6. Train and mentor team members on technical aspects and best practices in medical device regulations.

Skill Requirements

1. In-depth understanding of mdr regulations and medical device reporting processes.

2. Proficiency in implementing and managing iso 13485 quality management systems.

3. Experience in conducting process failure mode effect analysis (pfmea) in a regulated industry.

4. Strong analytical and problem-solving skills.

5. Excellent communication and interpersonal abilities to collaborate effectively with diverse teams.

6. Attention to detail and strong organizational skills to ensure compliance and quality standards are met.

Other Requirements

1.Relevant certifications in medical device regulations, ISO 13485, or PFMEA are a plus.