Sr. Staff Specialist, Quality Systems

We are the people who give possibilities purpose

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 Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description

Responsibilities:

This role must develop strategic quality programs to oversee and foster the following areas and represent QMS expert-level leadership and guidance for teams.

• QMS architecture: QMS certificate change notifications; change in scope of activities performed at sites; and site transfers
• QMS compliance: front room host for external audits and inspections; QMS expert to prep SMEs for front room; Management Review host; identifying QMS gaps in organizational structure, competency, or technical areas; implementing solutions to close QMS gaps, including but not limited to CAPAs, projects, workshops, and training; authoring CAPA investigations
• QMS harmonization activities: MMS lead for Inspire Quality program to harmonize processes with Global expectations and between MMS platforms (including Class I/II medical devices and non-medical devices)
• QMS integration activities: QMS impact assessments for integrating acquisitions, platforms, products, sites, etc.; due diligence activities for potential acquisitions

Required Qualifications:

• A BS degree in a technical field (Engineering, Science, Math/Stat)
• Minimum 8 years experience in Quality, Regulatory, or Operations of a Medical Device, IVD, Pharmaceutical or Biotech firm.
• Demonstrated expert-level knowledge of QMS.
• Ability to travel domestically and internationally, up to 25%
• Strong leadership skills with demonstrated ability to deliver excellent results
• Strong project management, team skills, and influential management
• Experience leading or supporting FDA and/or Notified Body inspections
• Excellent communication skills (up, down, and outward)

Preferred Qualifications:

• Experience in Regulatory Affairs preferred.
• Experience in metrics, data analytics, and/or statistical analysis preferred.
• ASQ certifications CQE, CSQE, CRE, CMQ/OE, CSSGB and/or CSSBB highly desired.

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 success.

To learn more about BD visit https://bd.com/careers.

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:

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Primary Work Location

USA CA - San Diego TC Bldg C&D:

Additional Locations

Work Shift

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information

$155,900.00 - $257,300.00 USD Annual