BD (Becton, Dickinson and Company) Staff Development Quality Engineer in San Jose, California
Job Description Summary
The Staff Development Quality Engineer is responsible for quality leadership and support of new product development and technology research projects for Biosciences Instruments and Reagents. This individual will ensure that the design control requirements are implemented and followed, will support multiple product development projects for Biosciences and will ensure that the quality objectives are met during the product development life cycle. This role will be an active mentor and coach to ensure products meet quality standards consistent with both Corporate and Business policies, while meeting all design control and other regulatory requirements. Specifically, this individual will leverage best practices in support of cross functional team leadership to drive excellence in areas such as customer requirement definition, product design and development and commercial launch. The staff quality engineer will ensure a mentality of collaboration, execution and continuous improvement while ensuring effective formal and informal communication mechanisms areemployed.
The Staff Quality Engineer reports to the Quality Director.
Independently manages and monitors quality needs of the new product project and all major projects as assigned. Escalates resource issues, constraints and delays to the quality director. Oversees and provides guidance to ensure that all activities are performed in accordance with quality system and regulatory requirements. Applies and mentors/coaches the application of technical principles, theories, concepts and quality tools to complex systems and process. Manages quality engineering support of Design Control activities, including quality planning, design verification & validation activities, design reviews, design transfer etc. Performs, mentors and coaches others on effective root cause investigations and corrective actions to maintain effective and compliant quality systems. Lead implementation and utilization of quality tools such as six sigma, risk management, SPC, root cause analysis, and DOE. Required to present management status updates.
Policy and Strategy
·Executes established strategy and direction associated with design control, change control, risk management, validations, supplier qualifications, SAs, CAPAs, statistics & sampling plans, and regulations.
Sphere of Influence
·Interacts internally with peers to negotiate and resolve conflicts. Understands and works to improve effectiveness of the BD matrix.
·Primarily focused within the Biosciences organization.
·Directs and controls the activities of quality engineers in support of core team objectives.
·Advances the talent bench strength of the company and builds bridges across the various departments to share and develop talent.
Impact of Decisions
·Decisions impact Biosciences and affect the financial, associate, or public relations position of BD.
·Requires in-depth knowledge of functional area, strategies, and BD’s goals. Responsible for executing to the business quality system. Has full understanding of quality and regulatory principles.
Education and Experience:
Minimum of B.S. in Engineering, Science (Chemistry or Physics). Master of Science in Engineering, Science is desired.
Minimum of 8 years' experience in quality engineering or similar engineering discipline.
Minimum of 5 years' experience supporting product development lifecycle (R&D, manufacturing, etc.) in Medical or pharmaceutical industry with responsibilities for quality management.
Strong understanding and implementation experience of design controls, 21CFR820, ISO13485, ISO 9001, ISO14971, IVDR and other applicable medical device regulations.
Sound understanding of basic quality engineering sciences, including statistical process control (SPC) methods and application, quality planning, failure analysis investigation, risk management and process and software validation.
Practical knowledge in design control and process control in a regulated industry.
Have a strong track record working with cross-functional product development teams.
Expert in delivering business critical goals within a phase gate based product development process.
Expert in the development of risk management, applications of six sigma and daily management tools to drive cohesion and velocity.
Strategic thinking and leadership skills; ability to develop strategies into clear actionable objectives and measurements. Ability to understand implications and impacts across multiple functions.
Skilled at facilitating team dynamics.
Possess the skills and aptitude to engage and influence other functions involved in the development of new products.
Demonstrated ability to influence without authority and deal effectively with ambiguity.
Drive for accountability within self and project team.
Demonstrated project management skills.
Demonstrated ability to make timely critical decisions.
The ability to prepare and understand technical documentation such as engineering drawings, operating procedures, work instructions, validations etc.
The ability to communicate effectively in writing and orally, to organize work and to achieve results when working alone or in teams.
Strong communication, problem solving, organizational and interpersonal skills.
CQE and/or CMQ/OE preferred.
Six-Sigma certification is preferred.
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 CA - San Jose
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.