Senior Quality Engineering Leader – Med Tech

Becton Dickinson; Irvine (CA); On-site; USD 165,000 - 263,000; Full time

Job summary

BD, a global medical technology leader, seeks an experienced Quality Engineer to own CAPA programs and drive cross-functional improvements at our Irvine facility. The role requires extensive Six Sigma, regulatory knowledge, and data-driven decision making.

You will mentor teams and partner with manufacturing, R&D, and QA to ensure robust processes. The ideal candidate has 8+ years in medical devices, a track record of project leadership, and strong communication skills to influence multiple

Qualifications

• Bachelor's degree in engineering required.
• Minimum 8+ years in medical device industry with failure analysis, complaint handling, and quality engineering.
• Proven leadership and project management experience in technical/engineering teams.

Responsibilities

• Lead cross-functional projects with accountable delivery of all milestones.
• Develop and implement CAPA programs, training, and system effectiveness.
• Provide technical design guidance for products and processes.
• Identify risks, define mitigations, and resolve issues with stakeholders.
• Drive data analysis, root-cause analysis, and continuous improvement initiatives.
• Collaborate with regulatory, R&D, and manufacturing teams to meet compliance.

Skills

Six Sigma Certification

Project management

Microsoft Office Suite

Problem-solving

Documentation & communication

Engineering procedures

Quality engineering processes

Regulatory knowledge (FDA, GMPs, ISO/É

Education

Bachelor's Degree in Engineering

Tools

Microsoft Office Suite

Job description

BD, a global medical technology leader, seeks an experienced Quality Engineer to own CAPA programs and drive cross-functional improvements at our Irvine facility. The role requires extensive Six Sigma, regulatory knowledge, and data-driven decision making.

You will mentor teams and partner with manufacturing, R&D, and QA to ensure robust processes. The ideal candidate has 8+ years in medical devices, a track record of project leadership, and strong communication skills to influence multiple