Senior Quality Engineer - MedTech: Design Controls & CAPA

Regulatory Jobs; Brea (CA); On-site; USD 106,000 - 169,000; Full time

Benefits offered by this job

Health & Well-being benefits

Retirement & Financial Well-being

Work-Life Balance & Family Support

Leave Programs

Job summary

BD is a leading global medical technology company seeking a Senior Quality Engineer to support new product development and maintenance under the Associate Director - Quality. The role ensures products meet quality standards and regulatory requirements through design control and robust CAPA processes.

Responsibilities include mentoring teams, driving continuous improvement, audits, and contributing to management reviews.

Qualifications

• Bachelor’s degree in a relevant field.
• 7 years of experience in quality or related field.
• 5+ years supporting design assurance for medical devices.
• Extensive knowledge of 21 CFR 820, ISO 13485, MDR/MDD, ISO 14971, ISO 10993.

Responsibilities

• Provides support/mentoring for application of technical principles and CAPA expert.
• Supports quality system audits.
• Inputs to the management review process.
• May perform other duties as required.
• Develops advanced technological ideas and guides their development into a final product.

Skills

Quality engineering

Statistics

Problem solving

Leadership

Interpersonal skills

Education

Bachelor's Degree

ASQ Certification desirable

Design for Six Sigma

Job description

BD is a leading global medical technology company seeking a Senior Quality Engineer to support new product development and maintenance under the Associate Director - Quality. The role ensures products meet quality standards and regulatory requirements through design control and robust CAPA processes.

Responsibilities include mentoring teams, driving continuous improvement, audits, and contributing to management reviews.