Skills: ISO 13485 standards, MDR regulations, Process Failure Mode Effect Analysis (PFMEA), analytical skills, collaboration, problem-solving, data-driven decision making, Quality Management Systems certifications, Medical Device Regulations certifications
Job Summary
As a Senior Technical Specialist focusing on mdr, medical iso13485 processes, and Process Failure Mode Effect Analysis (PFMEA), your primary responsibilities will include ensuring compliance with ISO 13485 standards, driving the implementation of mdr regulations, and leading the PFMEA process to mitigate potential risks in medical device manufacturing.
Key Responsibilities
1. Oversee and maintain adherence to iso 13485 standards in all relevant processes and documentation.
2. Implement and monitor compliance with mdr regulations related to medical device development and manufacturing.
3. Lead and conduct process failure mode effect analysis (pfmea)
to identify and address potential failure modes and risks in the manufacturing process.
4. Collaborate with cross functional teams to implement corrective and preventive actions based on pfmea findings.
5. Drive continuous improvement initiatives to enhance the reliability and quality of medical devices manufactured.
Skill Requirements
1. In-depth knowledge of mdr regulations and iso 13485 standards.
2. Proficiency in conducting process failure mode effect analysis (pfmea) in a medical device manufacturing setting.
3. Solid analytical skills to assess risks, define mitigation strategies, and drive process improvements.
4. Excellent communication and collaboration abilities to work effectively with multidisciplinary teams.
5. Problem-solving mindset and ability to make data driven decisions to ensure compliance and quality standards.
Other Requirements
1. Relevant certifications in Quality Management Systems and Medical Device Regulations would be a plus.