Quality Engineer I, Post Market Surveillance (PMS)
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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.
LIVING THE BD VALUES
We do what is right
We are committed to the highest standards of excellence and integrity in everything that we do: on behalf of our customers, our shareholders, our communities, and ourselves. We are proud to work for a healthcare company whose products and services make a difference in people’s lives. We derive our greatest sense of accomplishment from doing what is right – not what is expedient. We don’t compromise our high standards of ethics to achieve our objectives. We are reliable, honest, and trustworthy in all our dealings. We keep our promises and if we make a mistake, we make it right.
We take personal responsibility
Change is never easy, and despite our best efforts, it won’t all go smoothly. Being individually responsible means, we are accountable for our decisions, even when we make a mistake, and not try to place blame or make excuses. We treat the company's reputation as our own and try to make wise use of our time and the company's resources. We expect access to the tools and information necessary to participate in any decisions that will reflect on our collective or individual reputations.
We anticipate and address the challenges of patients and customers globally
It’s not enough to just respond to customer challenges. We need to know our customers’ needs as well or better than they do, so we can be proactive. Thinking about our customers holistically, including the patients they serve, will enable us to serve them better, helping to solve their most pressing healthcare challenges.
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.
We respect, collaborate, challenge and care about each other
We act with respect towards each other and towards those with whom we interact. We collaborate and challenge each other, cultivating best practices throughout the organization. We demonstrate constructive candor by disagreeing openly and dealing with our differences professionally. We care about people as individuals and promote an inclusive work environment that values, appreciates and leverages diversity.
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 product
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