Senior Quality Engineer - Medical Devices

BD; San Diego (CA); On-site; USD 151,000 - 207,000; Full time

Job summary

BD is a leading global medical technology company seeking a skilled Quality Engineer to support new product development and ongoing maintenance for medical devices. The role emphasizes design controls, regulatory compliance, and collaboration across engineering, manufacturing, and regulatory affairs.

Key activities include leading root cause investigations, CAPAs, and the use of statistical methods and quality tools (FMEA, SPC).

Qualifications

• Master’s degree in Engineering (any) or related field with 2 years of experience in quality engineering for medical devices.
• Alternative: Bachelor’s degree in Engineering (any) with 5 years of related experience.
• Experience with ISO 13485, 21 CFR Part 820.30, and ISO 14971 is required.
• Proficiency with quality tools (FMEA, SPC, CAPA) and statistical methods.

Responsibilities

• Support new product development and maintenance through quality engineering for medical devices.
• Participate in design control meetings and review product quality issues.
• Coordinate with engineering, manufacturing, regulatory affairs and suppliers to ensure compliance.
• Lead root cause investigations and implement corrective actions.

Skills

Statistical analysis

Quality tools

FMEA

Root Cause Analysis

TeamCenter

Polarion

AzureDevOps

TrackWise

Design controls

Education

Master’s degree in Engineering (any)

Bachelor’s degree in Engineering (any)

Tools

TeamCenter

Polarion

AzureDevOps

PLM systems

Job description

BD is a leading global medical technology company seeking a skilled Quality Engineer to support new product development and ongoing maintenance for medical devices. The role emphasizes design controls, regulatory compliance, and collaboration across engineering, manufacturing, and regulatory affairs.

Key activities include leading root cause investigations, CAPAs, and the use of statistical methods and quality tools (FMEA, SPC).