Sr. Staff Specialist, Quality Systems

We are the people who give possibilities purpose. We are the makers of possible. BD is one of the largest global medical technology companies in the world. Advancing the world of healthTM 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.

Requirements

• 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

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Tuition Reimbursement
• Relocation Assistance