MedTech Quality Engineering Leader

RXinsider LTD.; San Diego (CA); On-site; USD 179,000 - 323,000; Full time

Job summary

Becton, Dickinson, and Company (BD) seeks a Director of Quality Engineering to lead the quality function across design, development, and manufacture of medical devices, ensuring safety, efficacy, and regulatory compliance.

The role requires strategic leadership, hands‑on expertise in quality systems, and a track record of driving CAPA, risk management, and supplier quality across product lifecycles.

Qualifications

• Bachelor’s degree in Engineering or related scientific discipline.
• Minimum 10 years of progressive experience in Quality Engineering within the medical device industry.
• 5+ years in a leadership or management role.

Responsibilities

• Develop and implement a comprehensive quality engineering strategy aligned with regulatory requirements (FDA 21 CFR Part 820, ISO 13485).
• Lead, mentor, and develop a team of quality engineers in a high‑performance culture.
• Oversee design quality assurance, design controls, risk management, and design validation activities.
• Drive continuous improvement initiatives for manufacturing processes using CAPA and SPC.
• Collaborate with procurement and R&D to establish supplier quality programs and audits.
• Ensure regulatory compliance and prepare for internal and external audits.
• Provide quality engineering support throughout the product lifecycle, from concept to post‑market surveillance.
• Partner with R&D, Manufacturing, Regulatory Affairs to integrate quality into development and operations.
• Establish and monitor key quality metrics and report to senior leadership.

Skills

Quality Engineering

Leadership

Problem Solving

Regulatory Knowledge

Education

Bachelor's degree in Engineering

Master's degree preferred

Tools

FMEA

SPC

MSA

CAPA

Job description

Becton, Dickinson, and Company (BD) seeks a Director of Quality Engineering to lead the quality function across design, development, and manufacture of medical devices, ensuring safety, efficacy, and regulatory compliance.

The role requires strategic leadership, hands‑on expertise in quality systems, and a track record of driving CAPA, risk management, and supplier quality across product lifecycles.