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 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)
Requirements
Experience in Regulatory Affairs preferred.
Experience in metrics, data analytics, and/or statistical analysis preferred.
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 .
Required Skills
Optional Skills
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Primary Work Location
USA CA - San Diego TC Bldg C&D
Additional Locations
Work Shift
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.
Salary Range Information
$155,900.00 - $257,300.00 USD Annual
Benefits
Health insurance
Additional Information
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 MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.
Job Description
Becton Dickinson · - San Diego Tc Bldg C&d, CA