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
Be part of something bigger!
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. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
Our vision- Delivering solutions that minimize the burdens and complications associated with diabetes.
About the role
BD in Andover MA needs a new Senior Staff Quality Engineer to support new product development and maintenance for highly complex medical devices. You will handle projects from product inception through launch and maintenance while playing an active role in ensuring products meet quality standards and all regulatory requirements. This position develops highly advanced, new applications resulting in new products. Your decisions and recommendations will result in the achievement of goals critical to the major objectives of the company and would greatly enhance the image of the company’s quality technological capabilities.
- Directly responsible to the Plant Quality Manager for the continued consistent implementation/application of Quality Systems as it relates to new and current product lines and Enterprise business systems
- Is also responsible for assuring departmental compliance with ISO and FDA requirements through supporting internal and external audits, participation on teams, assigned project support, product launches and process improvements, CAPAs, product quality notifications, change notifications and customer complaints
- Provides consultation, guidance and work direction to colleagues and management and uses judgment to influence teams to drive impact on the business
- Provides critical direction to external designers, developers and manufacturers
- Leads and mentor’s other quality professionals on projects and provides coaching for application of technical principles, theories, concepts and quality tools and systems
- Develops advanced quality methods and guides their application into development of a final product, process or business opportunity.
- Advocate of quality culture
- Serves as BD Authority in the areas of design control and risk management and is accountable for Design Control requirements
- Ensures appropriate completion of all test method validations, software validations, and supplier qualification
- Develops and initiates Post Market Surveillance plan
Experience & education:
- B.S. degree, in life science, technical or engineering field. MBA or MS in a scientific field preferred
- ASQ Certified Quality Engineer, Six Sigma Black Belt or equivalent experience (preferred)
- A minimum of 15 years progressive experience in Quality within an FDA-regulated industry
Knowledge, skills and abilities:
- Extensive knowledge of applicable regulatory requirements and Quality System standards and regulations including 21 CFR 803 & 820, and ISO 13485 / ISO 14971
- Specialist in Design Controls
- Class II / III medical device experience. Strong understanding and application of six sigma methodology preferred. Ability to conduct internal / external Quality Systems audit
- Ability to prioritize multiple activities with varying business, compliance and customer drivers
Click on Apply if this sounds like you!
Why join us?
A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to encouraging an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
To learn more about BD visit https://jobs.bd.com/
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 MA - Andover
Work ShiftNA (United States of America)
What makes a successful Engineer Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.
- 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.