Staff Quality Systems Specialist - Post Market

Job Description Summary

Job Description

We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us.

• Under the direction of the Supervisor, conducts activities and procedures associated with DS Post Market Surveillance (PMS) Programs (EU IVDR, Health Canada, China PRER, etc.).
• Processes PMS reports including obtaining data from multiple sources, responses to additional questions on reports and general maintenance of the report files.
• Able to manage the end-to-end process of PMS reporting including utilization of the database systems used to process inputs to PMS.

• Responsible for processing PMS report requirements as defined in established procedures and processes and submitting to persons responsible per schedule.
• With limited guidance, completes PMS reporting for DS products per multiple country requirements and communicates/distributes as appropriate.

• Collate and analyse PMS data from a multi-disciplinary international team (Medical Affairs, Quality, Regulatory Affairs, Quality Compliance, Marketing, R&D/Engineering).
• Ensure reports are accurate, timely, relevant and complete.
• Work with Risk Management (RM) teams to feed PMS data back into the RM process.
• Work with a cross-functional team to complete Short-term PMS Plans and Short-term PMS Reports to track product performance after process/design changes (as needed).
• Identify and monitor patterns and market trends related to assigned product groups.
• Escalate high priority issues as well as identified business risks to the appropriate management level.
• Work closely with Manufacturing sites (both BD and Third Party), R&D and Quality
• Engineers as well as the International Marketing & Regulatory Departments to feed PMS data back into the design and/or manufacturing processes for both existing and future products.
• Work closely with the DS Quality Systems team to ensure Quality System Requirements are met in relation to the PMS process.
• Perform other duties as assigned.

• Knowledge of the medical device industry and Quality Management Systems (e.g. ISO13485)
• Strong analytical, deductive reasoning and listening skills
• Must be able to communicate precisely and accurately
• Strong business, technical and computer skills
• Using computer based analytical, statistical and modeling tools to identify and improve processes, must be proficient in excel and PowerBI, and be able to quickly develop proficiency in SAP and Trackwise
• Must be motivated, self-directed, and able to work with minimal supervision
• Ability and skill to effectively manage multiple tasks and lead execution of change management plans.
• Ability to work autonomously and to appropriately prioritize workload independently, involving high levels of planning and organizational skills
• Ability to effectively present information to management, public groups and/or customers
• Strong interpersonal skills, particularly in forming relationships with stakeholders and contributors across the business

• Minimum of BS Degree in Medical Technology, Biomedical Engineering or related healthcare / Engineering discipline.
• 3-5 years experience working in a regulated manufacturing environment or relevant healthcare setting highly preferred.