Senior Quality Engineer – Medical Devices & Design Control

Becton Dickinson; Brea (CA); On-site; USD 110,000 - 170,000; Full time

Job summary

BD is a leading medical technology company focused on turning health care into a better and more efficient experience. The Senior Quality Engineer will support new product development and product maintenance through quality engineering principles for medical devices, from inception through launch and ongoing maintenance.

The role involves leading design control, risk management, process validation, and CAPA activities, with emphasis on audits, regulatory compliance, and cross-functional

Qualifications

• 7+ years of relevant experience or equivalent education.
• 5+ years supporting design assurance for medical devices.
• Knowledge of 21 CFR 820, ISO 13485, MDR, ISO 14971, ISO 10993.
• ASQ certification desirable but not required.
• Design for Six Sigma preferred.

Responsibilities

• Mentors and coaches for application of quality principles and systems.
• Develops technical solutions for complex problems using quality tools.
• Leads design control / process control projects as core team member.
• Can serve as a CAPA expert.
• Supports quality system audits and management reviews.

Skills

Quality engineering

Statistics

Problem solving

Interpersonal skills

Leadership

Communication

Education

Bachelor's Degree

Job description

BD is a leading medical technology company focused on turning health care into a better and more efficient experience. The Senior Quality Engineer will support new product development and product maintenance through quality engineering principles for medical devices, from inception through launch and ongoing maintenance.

The role involves leading design control, risk management, process validation, and CAPA activities, with emphasis on audits, regulatory compliance, and cross-functional