Senior Quality Engineer - MedTech Design Control & CAPA

Becton, Dickinson and Company; 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

Becton, Dickinson and Company is seeking a Senior Quality Engineer to support new product development and product maintenance for medical devices. The role spans from product inception to launch, ensuring adherence to design controls and regulatory requirements. Collaboration across functions and mentoring of teams are key aspects.

Location is USA, CA – Brea, with additional San Diego presence. A strong background in quality systems, CAPA, risk management, and regulatory knowledge is required,

Qualifications

• Bachelor’s degree required in a relevant field.
• Minimum 7 years of relevant experience in medical devices.
• Minimum 5 years of experience supporting design assurance for medical devices.
• Extensive knowledge of regulatory and industry standards (21-CFR-820, ISO 13485, MDR, MDD, ISO 14971, ISO 10993).

Responsibilities

• Support/mentoring for application of quality engineering principles.
• Develop technical solutions for complex problems requiring ingenuity.
• Lead complex design control/process control projects.
• Act as CAPA expert and drive corrective/preventive actions.
• Support quality system audits and management reviews.
• Provide input to cross-functional teams and site leadership.

Skills

Quality engineering

Regulatory knowledge

CAPA

Design control

Risk management

Data analysis

Leadership

Problem solving

Education

Bachelor’s Degree

Job description

Becton, Dickinson and Company is seeking a Senior Quality Engineer to support new product development and product maintenance for medical devices. The role spans from product inception to launch, ensuring adherence to design controls and regulatory requirements. Collaboration across functions and mentoring of teams are key aspects.

Location is USA, CA – Brea, with additional San Diego presence. A strong background in quality systems, CAPA, risk management, and regulatory knowledge is required,