Job Summary

As a Senior Technical Lead specializing in mdr, medical iso13485 processes, and Process Failure Mode Effect Analysis (PFMEA), your primary responsibilities will include overseeing technical projects related to medical device regulations, quality management systems, and risk management processes to ensure compliance with ISO 13485 standards. You will be responsible for guiding a team of technical experts to develop and implement strategies for effective PFMEA in the medical device industry.

Job Purpose: As a Senior Technical Lead specializing in mdr, medical iso13485 processes, and Process Failure Mode Effect Analysis (PFMEA), your primary responsibilities will include overseeing technical projects related to medical device regulations, quality management systems, and risk management processes to ensure compliance with ISO 13485 standards. You will be responsible for guiding a team of technical experts to develop and implement strategies for effective PFMEA in the medical device industry.

Key Responsibilities: 1. Lead technical projects focused on mdr (medical device regulation) and iso 13485 processes.
2. Implement and maintain quality management systems to comply with industry regulations.
3. Conduct process failure mode effect analysis (pfmea) to identify and mitigate risks in medical device manufacturing processes.
4. Collaborate with cross functional teams to drive continuous improvement in quality and regulatory compliance.
5. Provide technical guidance and mentorship to team members on best practices in medical device regulations and risk management.
6. Stay updated on industry trends and regulatory changes to ensure adherence to the latest standards.
7. Analyze and report on key performance indicators related to quality and compliance metrics.

Skill Requirements: 1. In-depth knowledge of mdr (medical device regulation) and iso 13485 processes.
2. Proficiency in conducting process failure mode effect analysis (pfmea) in a medical device manufacturing environment.
3. Strong understanding of quality management systems and regulatory requirements in the healthcare industry.
4. Excellent project management skills to lead technical initiatives effectively.
5. Ability to communicate complex technical concepts clearly and concisely.
6. Leadership qualities to mentor and guide a team of technical professionals.
7. Problem-solving skills to identify and address compliance issues proactively.<

Other Requirements: 1.Relevant certifications in medical device regulations and quality management systems are preferred.

Key Responsibilities

1. Lead technical projects focused on mdr (medical device regulation) and iso 13485 processes.
2. Implement and maintain quality management systems to comply with industry regulations.
3. Conduct process failure mode effect analysis (pfmea) to identify and mitigate risks in medical device manufacturing processes.
4. Collaborate with cross functional teams to drive continuous improvement in quality and regulatory compliance.
5. Provide technical guidance and mentorship to team members on best practices in medical device regulations and risk management.
6. Stay updated on industry trends and regulatory changes to ensure adherence to the latest standards.
7. Analyze and report on key performance indicators related to quality and compliance metrics.

Skill Requirements

1. In-depth knowledge of mdr (medical device regulation) and iso 13485 processes.
2. Proficiency in conducting process failure mode effect analysis (pfmea) in a medical device manufacturing environment.
3. Strong understanding of quality management systems and regulatory requirements in the healthcare industry.
4. Excellent project management skills to lead technical initiatives effectively.
5. Ability to communicate complex technical concepts clearly and concisely.
6. Leadership qualities to mentor and guide a team of technical professionals.
7. Problem-solving skills to identify and address compliance issues proactively.

Other Requirements

1.Relevant certifications in medical device regulations and quality management systems are preferred.