Be part of something bigger at BD. Here, you’ll join a driven, agile engineering team working in a startup-like environment that has the backing and resources of a Fortune 500 company. In engineering, you could be involved in everything from operations, production and construction to information technology and maintenance environments, all while analyzing and developing solutions to further our engineering capabilities. You’ll use your talent and track record of solving complex problems to achieve one singular goal: advancing the world of health™. At BD, you can make a true difference of one.
Job Description Summary
The Sr. Quality Engineer is accountable for quality support for devices, products developed and process design to achieve these goals through active participation and contribution to multifunctional and multi-divisional teams. The incumbent will be capable of self- direction and project management to ensure successful outcomes.
Provide guidance and Quality oversight to ensure establishment and execution of robust design programs aligned with regulatory requirements and industry standards.
Support new product development and existing product sustaining activities to ensure work follows proper design
control. Ensure controls meet BD and FDA regulatory requirements by actively participating on product development
teams and identifying Quality needs, product improvements and customer requirements.
Ensures adequate design control documentation and records are maintained to support life cycle of design history.
Lead and supportnew product development execution ofdesign control and ensure tasks are completed adequately to include project
planning, design inputs, critical to quality characteristics, risk analysis, design reviews, validations, verifications, and
design history files and other activities as needed.
Responsible to evaluate design verification results and data utilizing statistical analysis to ensure design delivers an
acceptable quality level during manufacturing with properly established product specifications.
Ensures the design is appropriately specified and established before transferring into manufacturing to avoid increased risk.
Review and authorize Quality approval for new product and/or device design specifications including product
performance specifications, test methods, acceptance criteria, and release.
Support product and/or device continuous improvement initiativesby providing quality and regulatory requirements, approving protocols, assessing generated data and approving final reports.
Review and assess work performed by R&D and other BD business units to help ensure Quality issues with device(s) or component(s) are adequately addressed and when needed corrective actions are taken to prevent recurring quality issues.
Work with Validation team providing Quality Engineering support for Product and/or Device transfer, Scale-Up, and
Lead or participate in ISO 14971 Risk Management activities appropriate to the initiative or situation.
Monitor quality data from Product Incident Report process, Manufacturing reports, Service reports and customer
input. Identifies, investigates, troubleshoots and resolves identified quality issues independently or by working with
Manufacturing, Service, Engineering, Regulatory and Biostatics.
Initiate Corrective and Preventative Action plans and perform efficacy follow up.
Conduct as needed supplier evaluations and meet with suppliers to establish required controls to meet BD and
Participate as assigned with supplier capability and internal audits as a means of evaluating effectiveness of GMPs
and established Quality Systems.
Support Regulatory Affairs, as appropriate, by providing input for submissions or response to agency queries.
Support regulatory inspections as needed.
Support activities relating to Field Corrective Actions, when needed.
Provide guidance quality and training to other quality engineer to help increase knowledge of regulations and
standards for Devices and Combination Products.
Bachelor’s degree in STEM and six (6) years of engineering experience within a regulated industry, OR Master’s degree in STEM and four (4) years of engineering experience within a regulated industry required,
American Society of Quality (ASQ) certification (CQE, CQA, etc) preferred.
Experience in medical device industry strongly preferred.
Demonstrated knowledge of engineering principles through engineering experience including three (3) years of proven and effective project management skills.
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
Primary Work LocationUSA UT - Salt Lake City
Work ShiftNA (United States of America)
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Advancing the world of health™
BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
As a new employee what I like most about BD are the many learning and professional developmental opportunities for growth offered. It is good to know that there are so many resources to choose from.
Since joining BD, I really have liked the people I work with on a daily basis and the collaboration towards common goals.
Senior Program Manager
BD is full of passionate, loyal, and driven people that have a common goal of advancing healthcare without sacrificing quality or service.