Senior Quality Engineering Manager

Lead a team of Quality Engineers responsible for supporting software and systems projects for medical devices.

• Manage Quality Engineers to support new product development activities, maintain compliance to company procedures and external standards, manage design history files, create verification and validation documentation, participate in risk analysis activities, collaborate on product development deliverable documentation, identify system issues, summarize findings and prepare reports for key quality metrics.
• Be the quality and compliance representative in the assigned teams.
• Manage, mentor, and develop Quality Engineers on approach to design controls, agile design, risk management and product security.
• Build strong partnerships with cross-functional leaders to drive continuous improvement efforts, through facilitating, leading, and collaborating effectively.
• Manage and monitor day to day activities to ensure compliance with company policies and procedures (e.g. compliance with BD QMS, FDA and equivalent medical device regulations, internationally harmonized consensus standards, etc.).
• Quality support of US and international activities.
• Manage quality metrics and present them in management reviews.
• Responsible to assigned or being the prime quality representative for design control projects – new product development as well as sustaining efforts.
• When applicable, responsible for review and/or approval of design history file documentation in support of design controls.
• Manage all quality aspects of the design control process: quality planning; requirements generation and traceability, code reviews, integration testing, verification and validation planning and execution; risk management; regulatory, compliance and product security support.
• Lead the defect tracking process and management of issues prior to release and any issues that may present from the post-market surveillance teams.
• Quality representative in risk management activities including approval of risk management reports and risk analyses.
• When applicable, work closely with Program Management to ensure design deliverables are met and can be released to limited commercial and/or general release.
• Works together with SW Quality Engineers and R&D Leaders to ensure effective verification of design specifications and/or requirements.
• Review effectiveness of assessments of DHFs and Change Orders and/or Electronic Release Authorizations for new releases or design enhancements.
• Active participant in the development of product requirement, product system hazard analysis and design reviews.
• Work closely with Product Management and UX teams to ensure effective validation of user needs.
• Ensure product technical files and Design History Files are complete, traceable and auditable.
• Provide clarification and guidance to teams on overall quality system with emphasis in design controls.
• Provides decisions, recommendations, and results to further the achievement of goals critical to organizational objectives.
• Identifies areas requiring quality improvement and initiates and follows through plans of action (Quality Plans) necessary for implementation.
• Responsible to provide Quality support in 510k or International submissions as warranted.
• Successful completion of major programs/initiatives and may function in a project leadership role.

• Lead your team - guide, develop, mentor & grow associates to more significant contributions, capabilities & roles.
• Communicates effectively with cross-functional and execute team's objectives.
• Strong capability to influence people and teams in an indirect/matrixed organization.
• Excellent organizational skills to effectively manage several projects in parallel.
• Ability to quickly learn, understand and comprehend highly technical concepts.
• Extensive application of technical principles, theories, concepts and quality sciences, tools and systems.
• Uses analytical thinking and reasoning to anticipate implication/conclusions of a complex situation or issue.
• Makes tough decisions that impact the program, team, or individuals, while supporting decisions with clearly communicated rationale.
• Applies intermediate understanding of regulatory requirements (cGMP, FDA, ISO, etc.) to support work with little or no supervision
• Excellent understanding of design controls and risk management methodologies.
• Excellent understanding of Agile methodologies and software development life cycle.
• Teamwork oriented and ability to lead and influence without direct authority
• Able to work with minimum supervision.
• Able to manage regulated and non-regulated processes and improvements.
• Interprets internal and external business issues and adapts work priorities accordingly.
• Able to train Quality Engineers on overall quality approach to design controls, risk management and product security.
• Manage mix of guiding team members supporting projects & directly supporting projects of higher technical complexity.

• Bachelor's degree in engineering or life sciences.
• Minimum 10 years related experience in design and development.
• Minimum 3 years of management experience.
• Must be able to apply quality principles (ISO 13485, IEC 62304, 21 CFR, IEC 14971, etc.) to the R&D environment.
• Working knowledge of Cybersecurity design considerations, preferred.
• In-depth knowledge of software development life cycle and test methodology.
• ASQ certified (CQA, CQE, CSQE, CMQ) preferred.
• Experience dealing with SW only products preferred.

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.

To learn more about BD visit https://www.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 Location USA CA - San Diego TC Bldg C&D

Additional Locations

Work Shift

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You (https://www.bd.com/careers/our-commitment-to-you).

Salary ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary offered to a successful candidate is based on experience, education, skills, and actual work location. Salary ranges may vary for Field-based and Remote roles.

Salary Range Information $155, $256,000.00 USD Annual

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.