Senior Quality Engineer – Product Development

Abbott; Los Angeles (CA); On-site; USD 90,000 - 180,000; Full time

Benefits offered by this job

Health benefits

Retirement plan

Tuition reimbursement

Job summary

Abbott in Los Angeles, CA, seeks a Senior Development Quality Engineer to assure new or modified products meet quality standards and FDA/regulatory requirements.

You will lead design verification, risk management, DHF, audits, and cross-functional collaboration to protect patient safety and support commercialization.

Qualifications include 5+ years in quality engineering, FDA/GMP/ISO 13485 knowledge, and strong communication; travel up to 10%.

Qualifications

• Minimum 5 years of quality engineering experience with FDA, GMP, and ISO 13485 knowledge.
• Strong communication and interpersonal skills; ability to lead multi-department projects.
• Experience with cross-functional teams and regulatory inspections is required.
• ASQ CQE certification preferred.
• Design for Six Sigma/CTQ training preferred.

Responsibilities

• Create and ensure on-time execution of Quality Plans for development, OEM, CPDP and design changes.
• Lead Design Verification and Validation planning and execution with cross-functional analysis.
• Lead Risk Management from concept to commercialization.
• Develop and validate test methods and inspection plans.
• Ensure DHF content, regulatory compliance, and communicate gaps.
• Support manufacturing process development and qualification for new products.
• Coordinate internal & external audit responses and re-certifications.
• Establish objective product and component requirements and supplier qualifications.
• Develop biocompatibility and sterilization qualifications; manage documentation reviews.

Skills

Quality engineering

Project management

Leadership

Statistical analysis

Communication

Education

Bachelor's degree in Engineering/Technical Field

Master's degree (preferred)

Job description

Abbott in Los Angeles, CA, seeks a Senior Development Quality Engineer to assure new or modified products meet quality standards and FDA/regulatory requirements.

You will lead design verification, risk management, DHF, audits, and cross-functional collaboration to protect patient safety and support commercialization.

Qualifications include 5+ years in quality engineering, FDA/GMP/ISO 13485 knowledge, and strong communication; travel up to 10%.