Quality Engineering Manager - Medbank

Job Description Summary
Job Description
We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us.
Excited to grow your career?
We value our talented employees, and whenever possible strive to help one of our associates grow professionally before recruiting new talent to our open positions. If you think the open position you see is right for you, we encourage you to apply!
Our people make all the difference in our success.
In this role, you will be responsible for coordinating the activities of the quality function for new product development and sustainment on the BD Pyxis MedBank portfolio. Through internal and external stakeholder engagement and personnel development, this role ensures that projects design high quality products, compliant and on-time deliverables and efficient execution. Product safety, product quality, product reliability and compliance with all members of Core Teams and Program Management will be ensured through effective communication, excellent problem solving and active management of ambiguous situations.
This position leads design assurance engineers and is charged with defining and executing superior Quality practices, in accordance with The BD Way and Quality Management Systems, for: Design Quality Engineering, including sustaining design change activities, Software Quality Engineering (embedded, applications and analytics), Cybersecurity, Risk Management, Verification and Validation activities, Reliability Engineering, Human Factors, Test Method Development and Validation Safety Assurance Case practices.
The position will be a member of the Cross-functional BD Pyxis MedBank Platform Team and as such they and team leadership will represent the interests of Quality and Compliance.
This leader shall be proficient in the development of design process requirements and leading the core team through the necessary diligence and decisions related to conformance to those requirements throughout the new product development life cycle.
Accountabilities

• 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 FDA, BSI, CSA, etc.).
• 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.
• Manage all quality aspects of the design control process: quality planning; verification and validation planning and execution; risk management; regulatory, compliance and product security support.
• Quality representative in risk management activities including approval of risk management reports and risk analyses.
• Works with SW Quality Engineers and SW Quality Managers to ensure effective verification of design specifications and/or requirements.
• Work with Product Security Officer to ensure product security framework is implemented effectively.
• Monitor effectiveness of assessments of DHFs performed by Quality Engineers for new releases or design enhancements by conducting periodic audits.
• Responsible for the review and/or approval of Change Orders/Electronic Release Authorization to release product to Limited Commercial Release or General Release.
• 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.
• Lead training programs of Quality Engineers and R&D teams on areas of opportunity to effectively comply with the MMS QMS.
• 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.
• Successful completion of major programs/initiatives and may function in a project leadership role.

What is expected of you for success in your role

• Excellent communication skills to effectively work with cross-functional teams.
• Excellent organizational skills to effectively manage associates and projects in parallel.
• Ability to quickly learn, understand and comprehend highly technical concepts.
• In-Depth experience in the application of technical principles, theories, concepts and quality sciences, tools and systems.
• Makes tough decisions that impact the program, team, or individuals, while supporting decisions with clearly communicated rationale.
• Upper-Intermediate or advance understanding of regulatory requirements (FDA, ISO, MDR, etc.) to support the business.
• Upper-intermediate or advance understanding of design controls and risk management methodologies.
• Upper-intermediated or advance understanding of Agile methodologies and software development life cycle.
• Upper-intermediate or advance understanding of product security methodologies.
• Teamwork oriented and able to work with minimum supervision.
• Able to manage regulated and non-regulated processes and improvements.
• Accountable and reliable Quality Leader that lead by example.
• 20% project support and 80% quality management

Basic Qualifications:

• Bachelor's degree in engineering or life sciences.
• 10+ years related experience in design and development.
• ASQ certified (CQA, CQE, CSQE, CMQ) is a plus.
• In-depth knowledge of software development life cycle and test methodology.
• In-depth knowledge on FDA regulations and international standards
• Experience dealing with SW only products highly desired

For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
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://bd.com/careers
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.
PDN
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.
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
$121,100.00 - $199,800.00