Sr Design Quality Systems Manager

Sr Design Quality Systems Manager

The Sr Design Quality Systems Manager reports to the Director, Quality Management, WWIPD. The Sr Design Quality Systems Manager is responsible for the San Diego Design Center Quality Systems, Compliance, and for ensuring consistent application of Design Controls requirements and best practices.

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 usfrom design and engineering to the manufacturing and marketing of our billions of MedTech products per yearto 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.

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 effective and consistent application of design controls across all programs in scope of San Diego Design Center.
• Collaborates with core teams to establish Design Controls and Risk Management implementation strategies in compliance with internal, Industry, and Government Standards.
• Participates in Design Review meetings.
• Establish and maintain a Design Controls training program.
• 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.
• Ensure compliance of the San Diego Design Center QMS.
• Maintain effectiveness of the internal audit program
• Coordinates external audits and ensures that Design center sites are ready to manage external audits.
• 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 validation
• Quality functional support for implementation of electronic systems that that impact the QMS.

Scope of Responsibilities :

Required qualifications :

Preferred qualifications :

Knowledge and Skills :

At 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?

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.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally-protected characteristics.

Required Skills

Optional Skills

Primary Work Location : USA CA Brea

Additional Locations : USA CA - San Diego TC Bldg C&D

Work Shift : US BD 1st Shift 8am-5pm (United States of America)

At BD, we are strongly committed to investing in our associatestheir 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.