Quality Systems Leader

Job Description SummaryJob DescriptionWe are the makers of possibleBD 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.Reporting to the Senior Manager of QMS Strategy and Architecture, the Quality Systems Leader provides leadership to the MMS Quality Management Systems organization and develops and implements robust, compliant processes. This role leads implementation of QMS strategy, and assures alignment of tactics, to achieve the BD-wide Inspire Quality (IQ) initiative’s objectives for quality process integration and ongoing maintenance of an integrated QMS across MMS. Through outstanding communication, effective problem solving and active management of ambiguous situations, the Quality Systems Leader ensures process effectiveness and compliance with relevant procedures and regulations across MMS sites and locations.The incumbent will collaborate across functionally to ensure successful implementation and maintenance of business and compliance processes throughout the MMS Division. This position is expected to evolve and support a Continuous Improvement focus on overall QMS.The Quality Systems Leader will be expected to lead the activities related to QMS optimization and inspection/audit readiness.Responsibilities:• Provide support to QMS Strategy and Architecture management on QMS improvement, harmonization, and maintenance activities.• Work with workstream leaders and members to develop plans for effective implementation of global processes as well as new/revised standards and regulations• Support creation and review of QMS processes and other documentation to maintain alignment with scope of the QMS and existing certifications as well as site/platforms relationships• Assist teams with subject matter expertise on Quality Systems related standards, regulations, and programs such as, ISO 13485, 21 CFR 820, MDSAP, EU MDD/MDR, and ISO 9001.• Champion implementation of continuous process / product improvement strategies• Participate in preparation and leadership of internal/external audits and inspectionsQualifications:• Must be able to report to office as needed• Bachelor’s degree in science, engineering or other relevant discipline• Minimum of 8 years of relevant Medical Device experience across all areas of QMS process development and implementation.• ASQ certifications such as CQE, CSQE, CQA, CMQ/OE, CSSGB and/or CSSBB are preferred.• Ability to effectively lead and influence teams• Ability to evolve a quality system towards higher levels of performance, efficiency, and compliance• Strong knowledge of worldwide medical device regulations• Deep knowledge of quality processes such as CAPA, complaint management, risk management, root cause analysis, statistical sampling plans, corrections and removals and design controls including design verification/validation, and production process and purchasing controls.• Ability to make timely critical decisions regarding product quality and/or quality system compliance• Excellent leadership, communication, organization and project management skillsFor 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/careersBecton, 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 CA - San Diego TC Bldg C&DAdditional LocationsWork ShiftAt 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 USD Annual