Senior Quality Engineer – MedTech, CAPA & Design Control

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

Benefits offered by this job

Health & Well-being benefits

Retirement & Financial well-being

Work-Life Balance & Family Support

Leave Programs

Job summary

BD is a global medical technology leader seeking a Senior Quality Engineer to support new product development and maintenance. You will apply quality engineering skills to ensure design control and regulatory compliance throughout product lifecycles.

The role emphasizes CAPA expertise, data-driven decision making, and collaboration with cross-functional teams to drive quality improvements in medical devices.

Qualifications

• Bachelor’s Degree is required.
• 7+ years of relevant experience or equivalent education/experience.
• Minimum 5 years in design assurance for medical devices.
• Extensive knowledge of applicable regulatory/industry standards (21-CFR-820, ISO 13485, MDD/MDR, ISO 14971, ISO 10993).
• ASQ certificates desirable (not required).
• Design for Six Sigma preferred.

Responsibilities

• Provide mentoring/coaching for quality principles and act as a CAPA expert.
• Modify methodologies to continuously improve outcomes and support quality system audits.
• Contribute to management review inputs.
• Support design control, risk management, change control, and post-market activities.

Skills

Quality engineering

CAPA

Statistics

Problem solving

Leadership

Mentoring

Education

Bachelor's Degree

Tools

ASQ tools

CAPA system

Job description

BD is a global medical technology leader seeking a Senior Quality Engineer to support new product development and maintenance. You will apply quality engineering skills to ensure design control and regulatory compliance throughout product lifecycles.

The role emphasizes CAPA expertise, data-driven decision making, and collaboration with cross-functional teams to drive quality improvements in medical devices.