Quality Engineer II, Post Market Surveillance

Job Description Summary

The Quality Engineer II supports Post Market Surveillance activities through the collection, analysis, trending, and reporting on safety data to proactively identify potential adverse safety risks or performance trends. The incumbent will collaborate with cross‑functional team members to ensure compliance with the applicable regulations, standards, and company policies/procedures. This position plays an integral role in maintaining compliance with global regulations. This job description is intended as a summary of the primary responsibilities of and qualifications for this position.

The job description is not intended to be inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.

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 Med Tech 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.

• 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 BDX 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.
• Analyze and interpret PMS data
• Identify and elevate 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
• Maintain procedures, as necessary
• Support responding to requests for additional information from competent authorities, registries and notified body
• Working cross-functionally with Quality, Regulatory, Clinical Affair and Operations departments to fulfill ad‑hoc data requests and deliver detailed analysis of PMS data
• Develop and maintain knowledge of support systems including Master Control, JDE, Global Complaint System (GCS) and Power BI Tool Kit
• Performs other related duties and responsibilities as assigned
• Ability to travel up to 5% of the time

• Requires a minimum of a bachelor’s degree, Engineering Degree, or degree in a technical field
• Minimum of four years’ experience in engineering or quality engineering experience within the medical device, pharmaceutical, or equivalent industry

• Medical device experience working with Class I, II, and III devices
• Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.)
• Ability to develop solutions with business impact
• Working knowledge of statistical and risk assessment techniques
• Working knowledge of test method (development and validation), equipment qualifications, process and design validation, risk assessment techniques, and component qualification methodologies
• Ability to make and present risk-based decisions
• Strong interpersonal skills
• Ability to create and provide training
• Problem solving ability
• Ability to create, review and coordinate test protocols and reports
• Ability to generate engineering proposals
• Oral and written presentation skills
• Ability to lead cross functional teams
• Ability to provide analysis within strict timeline requirements and assuming accountability toward delivering on agreed upon commitments
• Understanding of regulatory requirements including ISO 13485, ISO 14971
• Proficient in Windows OS, Microsoft Office Suite particularly Power Point
• Proficient in…