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 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
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
SUPERVISION
Direct Workload Purpose
NA NA
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 observations.
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit https://bd.com/careers
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Required Skills
Optional Skills
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Primary Work Location
USA AZ - Tempe Headquarters
Additional Locations
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