Senior Quality Engineering Leader - Medical Devices

Becton Dickinson NA; San Diego (CA); On-site; USD 132,000 - 211,000; Full time

Job summary

Becton, Dickinson, and Company (BD) is seeking a Manager of Quality Engineering to lead the WWISD Design Center's quality strategy and team in San Diego, ensuring compliant QMS and robust design controls for medical devices.

The role focuses on quality system development, risk management, and cross-functional leadership to support new product development and manufacturing operations globally.

Qualifications

• Bachelor's degree in Engineering, Science or related discipline.
• 10+ years QA experience in FDA-regulated industry.
• 3+ years of direct management of QA staff.
• Extensive knowledge of 21 CFR 820, ISO 13485, ISO 14971, ISO 10993.
• Strong design quality assurance understanding.
• Desirable: DFSS or Six Sigma Green Belt/Black Belt.
• Excellent communication and leadership skills.
• Experience applying quality engineering tools and statistics.

Responsibilities

• Lead development and continuous improvement of quality systems per 21 CFR 820 and ISO 13485.
• Lead Risk Management per ISO 14971.
• Provide Quality Engineering support and statistics in design activities.
• Lead a team of Quality Engineers at the design center.
• Serve as Subject Matter Expert for Design Controls.

Skills

Quality Assurance

Design Controls

Risk Management

Statistical Analysis

Leadership

Regulatory Compliance

Process Validation

Project Management

Communication Skills

Quality Engineering Tools

Education

Bachelor's degree in Engineering or related discipline

Tools

Six Sigma

DFSS

Job description

Becton, Dickinson, and Company (BD) is seeking a Manager of Quality Engineering to lead the WWISD Design Center's quality strategy and team in San Diego, ensuring compliant QMS and robust design controls for medical devices.

The role focuses on quality system development, risk management, and cross-functional leadership to support new product development and manufacturing operations globally.