Global Quality Engineering Manager

Regulatory Jobs; 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, aligning with ISD Quality Leadership. The role provides quality engineering leadership, oversight, and direction to sustain a compliant QMS and support new product development and maintenance of medical devices.

The position requires expert knowledge of 21 CFR 820 and ISO 13485, expertise in risk management per ISO 14971, and the ability to lead a team of QA professionals in a

Qualifications

• Bachelor’s degree in Engineering, Science or related discipline.
• Minimum ten (10) years progressive experience in Quality Assurance within an FDA regulated industry.
• Minimum 3 (three) years of direct management experience of QA professional and technical staff.
• Extensive knowledge of 21 CFR 820, ISO 13485, ISO14971 and ISO 10993.
• Strong understanding of design quality assurance.
• Knowledge of DFSS, Six Sigma Green Belt or Black Belt desirable.
• 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 engineering leadership

Regulatory knowledge

Design Controls

Risk Management

Statistical Analysis

Project management

Leadership

Education

Bachelor’s degree in Engineering or related discipline

Tools

DFSS

Six Sigma

Job description

BD is seeking a Manager of Quality Engineering to lead the Quality Management strategy at the WWISD Design Center, aligning with ISD Quality Leadership. The role provides quality engineering leadership, oversight, and direction to sustain a compliant QMS and support new product development and maintenance of medical devices.

The position requires expert knowledge of 21 CFR 820 and ISO 13485, expertise in risk management per ISO 14971, and the ability to lead a team of QA professionals in a