Quality Systems Specialist: Medical Devices & Audits

Becton Dickinson NA; San Diego (CA); On-site; USD 106,000 - 169,000; Full time

Benefits offered by this job

Job summary

Becton, Dickinson, and Company is seeking a Quality Systems professional to maintain the IPD San Diego Design Center QMS and ensure audit readiness. You will lead audit activities, collaborate with R&D on Design Control, and drive improvements across quality processes.

Ideal candidates have a bachelor's degree in science, at least 2 years in medical device quality systems, and knowledge of QMS standards. Lead Auditor certification is a plus, with a strong emphasis on cross-functional

Qualifications

• Bachelor’s degree in science or related field.
• Knowledge of Design Control, Risk Management, and QMS processes.
• Minimum 2 years of experience developing and sustaining quality systems for medical devices.
• ISO 9001/13485 Lead Auditor certification desirable.

Responsibilities

• Maintain IPD San Diego Design Center Quality Management System and audit readiness.
• Escalate negative trends and support continuous improvement of the QMS.
• Subject matter expert for audits, measurement analysis, quality plans, and document control.
• Collaborate with R&D to ensure Design Control compliance and training guidance.
• Lead internal and external audit activities, including preparation and support.
• Develop action plans and track progress; implement procedures locally.
• Support management reviews and ensure alignment with requirements.
• Monitor monthly quality metrics and address negative trends.
• Maintain quality agreements with internal customers and suppliers.
• Provide training on quality processes and regulatory requirements.

Skills

Quality Management

Regulatory Compliance

Audit Readiness

Process Improvement

Education

Bachelor's degree in science

Job description

Becton, Dickinson, and Company is seeking a Quality Systems professional to maintain the IPD San Diego Design Center QMS and ensure audit readiness. You will lead audit activities, collaborate with R&D on Design Control, and drive improvements across quality processes.

Ideal candidates have a bachelor's degree in science, at least 2 years in medical device quality systems, and knowledge of QMS standards. Lead Auditor certification is a plus, with a strong emphasis on cross-functional