Quality Engineer II, Post Market Surveillance (PMS)

at  BD

JOB DESCRIPTION SUMMARY

We are looking for a Quality Engineer II, for our facility in BD Enniscorthy. You will support coordination and management of Post Market Surveillance reports through the collection, analyses, review, trending, and reporting on product safety data to proactively identify potential adverse safety risks or performance trends. The successful candidate will collaborate with cross functional team members to ensure compliance to the applicable regulations, standards, and company policies/procedures. This position plays an integral role in maintaining compliance with global regulations. The role will work closely with different functions onsite and between other BD sites in Europe and the US.

ABOUT THE ROLE

As Quality Engineer Post Market Surveillance you will support coordination and management of Post Market Surveillance reports through the collection, analyses, review, trending, and reporting on product safety data to proactively identify potential adverse safety risks or performance trends.
The successful candidate will collaborate with cross functional team members to ensure compliance to the applicable regulations, standards, and company policies/procedures. This position plays an integral role in maintaining compliance with global regulations. The role will work closely with different functions onsite and between other BD sites in Europe and the US.

MAIN RESPONSIBILITIES WILL INCLUDE:

• Work with a team to meet the requirements in generating periodic PMS related reports
• Identify development and training opportunities for PMS team along with Manager
• Participate in projects to align with BD Quality, MDD/MDR strategies and regulatory submissions
• Identify gaps and maintain PMS processes in compliance with global regulations
• Participate in PMS planning and reporting
• Extract and generate PMS and operational performance data necessary for generating applicable reports.
• Coordinate and provide oversight in the analysis of PMS data
• Identify and escalate instances when products are not achieving the intended performance based upon anticipated levels of frequency and/or severity
• Identify and evaluate new failure modes when encountered
• Support responding to requests for additional information from competent authorities, registries and notified bodies
• Work cross-functionally with Quality, Regulatory, Clinical Affairs, and Operations departments to fulfil ad-hoc data requests and deliver detailed analysis of PMS data
• Develop and maintain knowledge of support systems including Master Control, JDE