Quality Engineering Leader — Medical Devices

Becton Dickinson; 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 quality systems for the WWISD Design Center, ensuring compliance with 21 CFR 820 and ISO 13485, and guiding quality initiatives across design and development.

The role requires 10+ years of QA in FDA-regulated environments, 3+ years of management, and strong expertise in quality tools, risk management, and DFSS/Six Sigma methodologies. Located in San Diego, BD offers a collaborative, global environment.

Qualifications

• Bachelor’s degree in Engineering, Science or related discipline.
• Minimum ten years progressive experience in Quality Assurance within an FDA regulated industry.
• Minimum 3 years direct management experience of QA professional and technical staff.
• Extensive knowledge of applicable regulations and standards including 21 CFR 820, ISO 13485, ISO 14971 and ISO 10993.
• Strong understanding of design quality assurance.
• Manufacturing and project management experience is desirable.
• Knowledge of DFSS, Six Sigma Green Belt or Black Belt are desirable.
• Excellent communication, technical writing and leadership skills.
• Experience in applying Quality Engineering tools, statistics and problem-solving methodologies.

Responsibilities

• Lead development, sustenance and continuous improvement of quality systems compliant with 21 CFR 820 and ISO 13485.
• Execute, measure and report progress of Quality strategic initiatives.
• Ensure policies, procedures and systems produce products meeting quality and regulatory requirements.
• Provide Quality Engineering support and promote statistical tools in design and development activities.
• Lead Risk Management activities in compliance with ISO 14971.
• Support continuous improvement of quality and market competitiveness.
• Develop department skills and resources to maintain quality assurance effectiveness.
• Develop technical solutions to complex quality problems.
• Lead a team of Quality Engineers at the design center.
• Perform functional activities with minimal direction.
• Provide leadership for multidisciplinary projects.
• Serve as a site and functional Subject Matter Expert for Design Controls.

Skills

Quality leadership

Statistical analysis

Regulatory compliance

Cross-functional leadership

Quality engineering

Education

Bachelor’s degree in Engineering

Tools

DFSS

Six Sigma Belt

ISO 13485

Job description

Becton, Dickinson and Company (BD) is seeking a Manager of Quality Engineering to lead the quality systems for the WWISD Design Center, ensuring compliance with 21 CFR 820 and ISO 13485, and guiding quality initiatives across design and development.

The role requires 10+ years of QA in FDA-regulated environments, 3+ years of management, and strong expertise in quality tools, risk management, and DFSS/Six Sigma methodologies. Located in San Diego, BD offers a collaborative, global environment.