Design Quality Post Market Surveillance (PMS) Senior Supervisor

at  Boston Scientific Corporation

MINIMUM QUALIFICATIONS:

• Bachelor’s degree in engineering, science, or a related field.
• Experience: 5 years in similar positions.
• English Level desired: Fluent.
• Previous experience with Project management.
• Strong communication and presentation skills, with the ability to translate performance and issues to various audiences.
• Experience working in a regulated environment.
• Ability to collaborate and influence across multiple, cross-functional teams.
• Demonstrated experience leading projects and coordinating priorities based on business and department objectives.

PREFERRED QUALIFICATIONS:

• Previous experience with Post Market Surveillance activities or related area.
• Experience with Quality System Regulations, Medical Device Regulation, and Quality Standards.
• Understanding of risk management and familiarity with Post Market requirements
• Experience working across multiple product areas and cross-functionally

ABOUT THE ROLE:

The Post Market Surveillance (PMS) Supervisor will oversee the PMS activities for the DQA Endoscopy division, ensuring compliance with regulatory requirements, internal policies and on time delivery. This role involves leading a team of professionals, managing cross-functional projects, and serving as a subject matter expert (SME) during audits. The PMS Supervisor will also be responsible for developing and maintaining tools and processes to analyze and report on product field performance, complaint reduction and fostering a collaborative work environment.

YOUR RESPONSIBILITIES WILL INCLUDE:

• Supervise and mentor the PMS team, providing guidance and support.
• Lead and coordinate complaint reduction and post-marketing projects and initiatives.
• Assign resources, manage the cadence, and ensure timely completion of PSURs (Periodic Safety Update Reports) and PMSPs (Post Market Surveillance Plans).
• Support internal audit requests and provide necessary documentation and information.
• Support the submission of PSURs to regulatory bodies and support any follow-up questions or requests.
• Serve as the SME for PMS processes during internal and external audits.
• Champion and ensure that Endoscopy practices are in compliance with Global and external standards.