Senior Quality Engineer - MedTech Design & CAPA Leader

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

Job summary

BD in the United States (CA, Brea) seeks a Senior Quality Engineer to support new product development and product maintenance within medical devices. You will apply quality engineering skills to ensure design control and regulatory compliance across product lifecycles.

Responsibilities include mentoring teams, guiding CAPA actions, improving methodologies, and participating in management reviews. This role requires collaboration across functions and potential audits.

Qualifications

• Bachelor’s degree required.
• 7+ years relevant experience in medical devices.
• 5+ years of experience supporting design assurance for medical devices.
• Regulatory and industry standards knowledge: 21-CFR-820, ISO 13485, MDD/MDR, ISO 14971, ISO 10993.

Responsibilities

• Provides support/mentoring for quality principles and systems; can serve as a CAPA expert on complex design control / process control projects.
• Modifies methodologies and procedures, ensuring continuous improvement of desired outcomes; supports quality system audits.
• Provides input to the management review process.
• May perform other duties as required.

Skills

Quality engineering tools

Statistics

Problem solving

Interpersonal skills

Leadership

Communication

Education

Bachelor's Degree

Tools

ASQ Certificates

Job description

BD in the United States (CA, Brea) seeks a Senior Quality Engineer to support new product development and product maintenance within medical devices. You will apply quality engineering skills to ensure design control and regulatory compliance across product lifecycles.

Responsibilities include mentoring teams, guiding CAPA actions, improving methodologies, and participating in management reviews. This role requires collaboration across functions and potential audits.