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
As directed by the Quality Sr. Manager, the Quality Engineer II is accountable for supporting new product development and product maintenance on the BD MDS Hazardous Drug Safety (HDS) product platform through the application of Quality engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements.
Position specific responsibilities include support of the following, however are not limited to:
Design Verification plans, protocols, and reports
Design History File support
Identification of CTQ's
Unit Quality Independent Reviewer During Design Reviews
Handling of deviations and non-conformances
Test method validations
Post Market Surveillance
CAPA – Root cause investigation and implementation of corrective / preventive actions
Proper Use of Statistics (Sampling Plans)
Advise on Regulations
Liaise with Manufacturing Plants
Provide functional support to cross-functional teams
Internal and external audits
Contributes to the completion of milestones associated with specific projects.
Prepares reports, including quantitative / qualitative analysis, summaries and protocols.
Sphere of Influence:
Under general supervision; plans, designs and performs development as assigned.
Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions to problems with broad scope and complexity.
Plans and participates in disciplines strategically relevant to the business and/or functions
May be assigned as extended core team member for sustaining or new product development projects
Moderate knowledge of applicable medical device and/or pharmaceutical regulatory, Corporate and/or Unit requirements.
Training in statistics. Class II / III medical device experience (preferred). Knowledge of design control principles (preferred). Ability to provide support to internal / external audits.
Typically requires a minimum of a Bachelor’s Degree
A minimum of 2 years relevant experience or a combination of equivalent education and relevant experience in medical device or pharmaceutical industries.
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.
Primary Work LocationUSA NJ - Franklin Lakes
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- Team player
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.