Global Quality Engineering Manager - Medical Devices

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

Job summary

BD is seeking a Manager of Quality Engineering to lead the Quality Management strategy at the WWISD Design Center, ensuring compliance with 21 CFR 820 and ISO 13485 while supporting new product development and maintenance.

You will supervise Quality Engineers, apply statistical tools, drive risk management per ISO 14971, and champion continuous improvement across global teams to sustain quality and market competitiveness.

Qualifications

• Bachelor’s degree in Engineering, Science or related discipline.
• 10+ years of QA experience in FDA regulated industry.
• 3+ years of direct QA management experience.
• Strong knowledge of 21 CFR 820, ISO 13485, ISO 14971 and ISO 10993.
• DFSS/ Six Sigma Green Belt or Black Belt desirable.
• Experience applying Quality Engineering tools, statistics and problem-solving methodologies.

Responsibilities

• Lead development and improvement of quality systems per 21 CFR 820 and ISO 13485.
• Execute and report progress of quality initiatives.
• Ensure processes meet quality and regulatory requirements.
• Provide Quality Engineering support and promote statistical tools.
• Lead Risk Management per ISO 14971.
• Develop department skills to sustain QA effectiveness.
• Lead a team of Quality Engineers at the design center.
• Serve as SME for Design Controls.

Skills

Quality Assurance

Design Controls

Statistical Analysis

CAPA

Leadership

FDA Regulations

Education

Bachelor's degree in Engineering, Science or related discipline

Job description

BD is seeking a Manager of Quality Engineering to lead the Quality Management strategy at the WWISD Design Center, ensuring compliance with 21 CFR 820 and ISO 13485 while supporting new product development and maintenance.

You will supervise Quality Engineers, apply statistical tools, drive risk management per ISO 14971, and champion continuous improvement across global teams to sustain quality and market competitiveness.