Electrical Development QA Engineer II – Cardiac Rhythm

Regulatory Jobs; Los Angeles (CA); On-site; USD 82,000 - 141,000; Full time

Job summary

Abbott in Sylmar, CA, is seeking an Electrical Development Quality Engineer II to ensure products meet quality standards and regulatory requirements. This on-site role collaborates with cross-functional teams to protect patient safety and support product development from concept through commercialization.

The position requires a Bachelor's in engineering or technical field and at least 2 years in quality engineering, with strong communication and ability to work in a matrixed environment.

Qualifications

• Bachelor’s Degree in Engineering or Technical Field or an equivalent combination of education and work experience.
• 2 years of quality engineering experience and demonstrated use of Quality tools/methodologies
• Experience in a broader enterprise/cross-division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse environment.
• Strong verbal and written communications; effectively communicate at multiple levels in the organization.

Responsibilities

• Execute and support on-time completion of Design Control Deliverables.
• Accountable for Electrical Design Verification and Validation planning & execution, including cross-functional root-cause analysis and resolution.
• Lead or support Risk Management activities from product Concept through Commercialization.
• Support electrical design test and inspection method development, and lead method validation activities.
• Ensure DHF content completion, integrity, and regulatory & standards compliance; communicate and resolve gaps.
• Support manufacturing process development & qualification for new product commercialization and product changes.
• Support internal & external audits and audit responses.
• Support product re-certifications.
• Support establishment of objective, measurable product requirements and supplier qualifications.
• Complete Document Change Request Reviews in a timely and objective manner.

Education

Bachelor’s Degree in Engineering or Technical Field

Master’s Degree

Job description

Abbott in Sylmar, CA, is seeking an Electrical Development Quality Engineer II to ensure products meet quality standards and regulatory requirements. This on-site role collaborates with cross-functional teams to protect patient safety and support product development from concept through commercialization.

The position requires a Bachelor's in engineering or technical field and at least 2 years in quality engineering, with strong communication and ability to work in a matrixed environment.