Senior Quality Engineering Manager – MedTech

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

Job summary

BD is seeking a Manager, Quality Engineering to lead QMS strategy at the WWISD Design Center in San Diego. You will guide quality leadership, regulatory compliance, and product integrity across new development and maintenance of medical devices.

The role requires long-term QA leadership with extensive FDA/ISO knowledge, and strong cross-functional collaboration to drive continuous improvement and risk management for BD devices.

Qualifications

• Bachelor’s degree in Engineering, Science or related discipline.
• 10+ years QA experience in FDA-regulated environment.
• 3+ years of direct QA leadership/management.
• Strong knowledge of 21 CFR 820, ISO 13485, ISO 14971, ISO 10993.

Responsibilities

• Lead development, sustenance and improvement of QMS per 21 CFR 820 and ISO 13485.
• Execute, measure and report progress of Quality strategic initiatives.
• Ensure policies and systems meet quality and regulatory requirements.
• Provide QA engineering support and promote statistical tools in design.
• Lead risk management activities in ISO 14971 compliance.
• Develop skills in the team to maintain QA effectiveness.
• Serve as site/functional SME for Design Controls.

Skills

Quality engineering leadership

Regulatory compliance

Statistics & tools

Design Controls

Risk management

CAPA & root cause

Cross-functional leadership

Process improvement

DFSS/ Six Sigma

FDA/ISO knowledge

Education

Bachelor’s degree in Engineering or Science

Tools

DFSS

Six Sigma (Green/Black Belt)

Statistical tools

Job description

BD is seeking a Manager, Quality Engineering to lead QMS strategy at the WWISD Design Center in San Diego. You will guide quality leadership, regulatory compliance, and product integrity across new development and maintenance of medical devices.

The role requires long-term QA leadership with extensive FDA/ISO knowledge, and strong cross-functional collaboration to drive continuous improvement and risk management for BD devices.