Sr. Staff Specialist, Quality Systems

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 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.
• ASQ certifications CQE, CSQE, CRE, CMQ/OE, CSSGB and/or CSSBB highly desired.
• Why Join Us?
• 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
• .
• 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

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

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