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 Senior Staff Quality Engineer is accountable for supporting new product development and product maintenance through the application of quality engineering skills for highly complex 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. This position develops highly advanced, new applications resulting in new products. Decisions or recommendations would normally 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.
- The Senior Staff Quality Engineer is accountable for supporting new product development and product maintenance through the application of quality engineering skills for highly complex 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. This position develops highly advanced, new applications resulting in new products. Decisions or recommendations would normally 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.Develops quality strategy for large-scale, highly challenging programs with outstanding initiative and innovation
- Contributes to long-range business strategies, choosing disciplines and methods appropriate to the work content and context.
- Often acts independently on issue resolution, projects and other assignments. Works under consultative direction toward predetermined long-range, business strategies in creative and effective ways
- Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results on new assignments
- Provides consultation, guidance and work direction to colleagues and management and uses judgment to influence within and across functions to drive impact on the business/function
- Provides critical direction and oversight to external designers, developers and manufacturers
- Leads and mentors other quality professionals on complex projects and provides mentoring / coaching for application of technical principles, theories, concepts and quality tools and systems.
- Leads cross functional teams through design control activities throughout the structured development process.
- Develops advanced quality methods and guides their application into development of a final product, process or business opportunity.
- Primary core team member/extended team member for complex design control / process control projects.
- Serves as a change agent and advocate of quality culture
- Serves as BD Subject Matter Expert in the areas of design control and risk management and oversees completion 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 a scientific, technical or engineering discipline. Master in business or scientific discipline 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.
- Expert 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.
- Training in design of experiments and statistics.Comprehensive knowledge of Quality System standards and regulations including 21 CFR 803 & 820, and ISO 13485 / ISO 14971
- Knowledge and experience in manufacturing, project management and engineering.
- Must possess excellent oral and written communication skills, and proven supervisory/leadership capability.
- Demonstrated ability to understand and communicate complex technical, statistical and compliance subject matter
- Ability to manage and prioritize multiple activities with varying business, compliance and customer drivers.
- Ability to lead and mentor quality engineers as well as other cross-functional core team members.
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)
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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.