Sr. Staff Specialist, Quality Systems

Responsibilities 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. Experience in metrics, data analytics, and/or statistical analysis. ASQ certifications CQE, CSQE, CRE, CMQ/OE, CSSGB and/or CSSBB highly desired. Primary Work Location USA CA - San Diego TC Bldg C&D Salary Range Information $155,900.00 - $257,300.00 USD Annual 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. #J-18808-Ljbffr BD Mexico