Sr. Staff QMS Specialist

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. 

This position is a limited term assignment which will include benefits such as (medical, health, dental, 401k). Eligibility for these benefits will be based on the eligibility requirements as determined by the BD Total Rewards policy, and is anticipated to last approximately through March 31, 2026.

Job Summary:
The Sr. Staff Quality Specialist participates and may lead the development, implementation, and maintenance of the  Quality Management System. The individual in this role must work cross functionally both horizontally and vertically within the organization.

Job Responsibilities: 

• Responsible for managing all aspects of Quality Planning to ensure timely completion of deliverables and closure of Quality Plans

• Proactively engage stakeholders to drive consensus and resolve issues in a timely fashion

• Knowledgeable in verification/ validation process, risk management, design controls, and quality compliance areas to drive technical discussions and remove roadblocks

• Take a leading role in the development, implementation and maintenance of Quality System processes required for compliance to FDA 21 CFR 820, MDSAP, ISO 13485, and ISO 9001. 

• Work collaboratively with functional teams to guide and/or facilitate QMS requirements, Continuous Improvement, and Audit Support.

• Facilitate Continuous Improvement projects and investigations including data analysis, root cause analysis and development of action plans to support the QMS.

• Coordinate or lead Quality related projects. Maintain and manage positive working relationships both vertically and horizontally within the organization while leading and/or assisting in all stages of Quality Management System activity and projects.

• Participate or lead other Quality and Transition Projects.

Education and Experience:

• Bachelor of Arts (BA), Bachelor of Science (BS) in related field

• Minimum of 8 years experience with emphasis on participating and leading projects within Medical Device QMS space

Knowledge and Skills:

• Strong knowledge of quality management systems and industry related regulations (FDA 21 CFR 820, ISO 13485, MDSAP, ISO 9001).

• Strong interpersonal skills including decision making, persuasion, effective communication, objectivity, assertiveness, and thoroughness.

• Hold self and others accountable to deliver on commitments.

• Ability to implement processes and systems.

• Excellent ability to apply a systematic and analytical approach to problem solving.

• Ability to create, write, and present material, adjusting to the level of the audience.

• Knowledge and experience in process analysis, root cause investigation and risk management.

• Ability to develop solutions and effectively collaborate with all levels of staff while maintaining an appropriate assertive style.

• Effective project management and organizational skills.

• Ability to influence without authority coupled with ability to work collaboratively and effectively communicate with peers and management across all functions. May function in a leadership or project leadership role.

• Will interface with internal or 3rd party audits (e.g. FDA, Notified Body, etc.).

• Considered Site / functional level Subject Matter Expert in assigned areas of Quality Systems.

• Software development experience within a regulated environment is preferred 

Work Environment: 

• Remote

This position is a temporary assignment. This position will support remediation activities within MMS and is anticipated to last approximately through March 2026.

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.  

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. 

Required Skills

Optional Skills

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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 or hourly rate 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 or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.

Salary Range Information

$155,900.00 - $257,300.00 USD Annual