JOB DESCRIPTION SUMMARY

We are looking for a Quality Engineer I, for our facility in BD Peripheral Intervention. 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.

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.

WE INNOVATE AND IMPROVE CONTINUOUSLY

Innovation isn’t specific to R&D and new product development, nor is continuous improvement limited to our operations and manufacturing teams. We are all accountable for seeking innovative solutions to our challenges and for not settling for “good enough” but striving to improve and be better every single time. We study our progress and learn from others and ourselves how to do things more effectively and efficiently.

REQUIRED QUALIFICATIONS

• Apply project management tools to ensure reports are submitted based on the commitment timelines
• Ability to make and present risk-based decisions
• Strong interpersonal skills
• Problem solving ability
• Ability to create, review and coordinate reports based on established guidelines and regulatory requirements
• Oral and written presentation skills
• Ability to provide analysis within strict timeline requirements and assuming accountability toward delivering on agreed upon commitments

EDUCATION AND/OR EXPERIENCE

• Requires a minimum of a bachelor’s degree, Engineering Degree, or degree in a technical field
• Proficient in Windows OS, Microsoft Office Suite
• Proficient in Excel in manipulation of data

PREFERRED KNOWLEDGE AND SKILLS

• Medical device experience working with Class l, ll, and lll devices
• Experience in technical writing and project management
• Ability to develop & maintain dashboards using BI tools

RESPONSIBILITIES INCLUDE, HOWEVER ARE NOT LIMITED TO:

• Work with a team to meet the requirements in generating periodic PMS related reports
• 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
• Maintain procedures, as necessary
• 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 fulfill ad-hoc data requests and deliver detailed analysis of PMS data
• Develop and maintain knowledge of support systems including Master Control, JDE
• Performs other related duties and responsibilities as assigned