Sr. Design Quality Systems Manager

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 DescriptionReports to the Director, Quality Engineering, WWIPD. The Sr Design Quality Systems Manager is responsible for the San Diego Design Center Quality System Compliance, and for ensuring consistent application of Design Control requirements and best practices.Responsibilities:Maintain and improve the IPD San Diego Design Center Quality System, provide strategic direction so that the QS architecture support the business needs and future growth. Establish and maintain QMS linkages with all entities that interact with the IPD San Diego Design Center. Maintains quality agreements.Monitor the effectiveness of the QMS, review key indicators, address negative trends, and prepare Management Review meetings.Maintain effectiveness of the CAPA process. Ensure compliance of the San Diego Design Center QMS, maintain effectiveness of the internal audit program, coordinate external audits and ensure that Design center sites are ready to manage external audits.Ensure effective and consistent application of design controls across all programs in scope of San Diego Design Center; Participate in Design Review meetings and establish and maintain a Design Controls training program.Collaborates with core teams to establish Design Controls and Risk Management implementation strategies in compliance with internal, Industry, and Government Standards.Responsible for Risk Management system. Ensures consistent application of risk management, its effectiveness, and for maintaining compliance with internal, Industry, and Government Standards.Responsible for establishing and maintaining linkages between Risk Management and other processes such as Post Market Quality, Design Control, and Change Control.Provide Quality functional support for labeling programs and labeling process improvement activities.Implement, Measure and Report on the progress of the Quality Management Strategic initiatives, such as Inspire Quality.Software validationQuality functional support for implementation of electronic systems that that impact the QMS.Scope of Responsibilities Leads a team of specialist that support the Quality Management System, including the CAPA and internal audit processes.Assignments are often self-initiated. Determine and pursue course of action necessary to obtain desired results.Participates in, and may provide leadership for multi-disciplinary projectsConsidered Site Quality Management System Subject Matter Expert, including Design Controls and Risk Management.Required qualifications:Bachelor's Degree required in engineering or life sciences related field.  Minimum ten (10) years progressive experience maintaining a Quality System within an FDA regulated industry; QMS administration and planning experience, required.Minimum 3 (three) years of direct management experience of QA professional and technical staffExpertise in regulations affecting medical devices marketed in all regions throughout the world.Expertise in failure investigation and medical device CAPA process.  Experience in medical device product development and application of Design Controls in a Design Center.Proven understanding of design quality assurance.  Experience managing regulatory audits and responding to regulatory authorities.Proven leadership capability and teamwork across functions and regions.Ability to manage complex situations and make sound decisions.Preferred qualifications:Certified as Engineer or Auditor by the American Society for Quality (ASQ).Lead Quality System Auditor experienceGreen Belt or Black Belt from a recognized program.Knowledge and Skills:Quality Management Systems requirements for medical devicesKnowledge and applied experience of 21CFR,  MDD 93/42/EEC, MDR 2017/745, ISO13485Quality system auditingManagement of notified body audits.Risk ManagementChange control.Test method validationsCAPA – Root cause investigation and implementation of corrective/ preventive actionsExcellent oral and written communication skills, assertiveness skillsGood written and oral communication  Cross functional team collaboration and influencing.Critical thinking and analytical skillsAt BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.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?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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive. We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your succe