Sr. Director Quality Systems

Skip to main contentWe use cookies and other tracking technologies to assist with navigation, improve our products and services, assist with our marketing efforts, and provide content from third parties. By continuing to use this site you agree to our use of cookies in accordance with our privacy policy. Manage third-party cookie preferences hereDeclineAccept CookiesEnglishSign InSr. Director Quality Systems page is loadedSr. Director Quality SystemsApplyremote typeIn-OfficelocationsUSA CA - San Diego Bldg A&Btime typeFull timeposted onPosted 30+ Days Agojob requisition idR-543127 We are the people who give possibilities purposeBD 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. Job DescriptionWe 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.This role will lead all aspects of the Medication Management Solutions (MMS) entities, including but not limited to, San Diego and Tijuana, to seek quality system harmonization across the entities and to drive these systems to meet changing regulatory demands (e.g., MDR, QMSR). Drive the design, development, and implementation of these QMS processes with corporate and business objectives. In some cases, the actual ownership of these processes will be by other MMS QA leaders. Complete the integration of the MMS QMS into the larger BD QMS and Inspire Quality (IQ) initiatives. Drive the MMS QMS upgrade project that seeks to achieve compliance with EUMDR and seeks to drive QMS efficiency and effectiveness.  Act as the point person for internal and external audits and inspections, with organizational skills and strong communication to regulatory agencies.  Coordinate external MMS communications with regulators to establish consistency and trust. Act as the point of contact for internal and external audit actions.Responsibilities: Drive MMS Quality Systems strategy as follows: Compliance – Ensure compliance with global regulatory standards for medical devices and non-medical devices across various physical locations and entities. Effective and efficient Quality Management — Ensures the MMS QMS is efficient, compliant and simplified to promote the best quality practices. Leadership – Leads or influences quality networks, businesses, associates and capital resources toward the effective promotion and alignment of organizational goals to the company’s mission and vision. Demonstrates strong big-picture thinking; effectively integrates and balances long-term opportunities and challenges, with day-to-day activities. Understands implications of decisions and communications both written and verbal. Innovation— The MMS product development process is conducted under the MMS QMS. This QMS must be streamlined to develop new products and change management practices to ensure we deliver a compliant world class customer experience. Growth - Responsible for the effectiveness of the MMS QMS. An effective QMS delivers high performing, safe products that meet and exceed customer expectations. Qualifications: The candidate should have at least a BS degree...