Quality Engineer , Post Market Surveillance; PMS

Position: Quality Engineer I, Post Market Surveillance (PMS)
We are the people who give possibilities purpose

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.

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 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.

RESPONSIBILITIES

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

* Ability to travel up to 5% of the time

QUALIFICATIONS

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

PHYSICAL DEMANDS

While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.

Work Environment:

While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce. On occasion the employee may work in a preclinical setting like an animal lab, cadaver lab or attend clinical case…