Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.

The position of Quality Engineer IV is within our Cardiometabolic business unit located in San Diego, California. This role is responsible for quality engineering activities, to monitor and measure Abbott compliance with the Quality System Regulation, Abbott Quality policies, FDA and ISO regulations as well as Abbott product quality and compliance objectives.

This job description will be reviewed periodically and is subject to change by management.

RESPONSIBILITIES:

• Lead Risk Management activities using the Failure Mode and Effect Analysis methodology (e.g. sFMEA, dFMEA, pFMEA).
• Lead the development of mitigations for failure modes and verify the effectiveness of these mitigations.
• Support the change control process by reviewing proposed changes, performing risk assessments, and assessing the adequacy of verifications and validations.
• Lead NC and CAPA activities such as risk assessments, root cause investigations, and action plans.
• Provide resolution of quality issues identified by production and project teams in accordance with established procedures.
• Lead Quality requirements within the design transfer, design control and improvement project teams.
• Support the complaint process by performing investigations
• Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
• Other duties as assigned, according to the changing needs of the business.

MINIMUM QUALIFICATIONS | EDUCATION/EXPERIENCE:

• B.S. degree; or the equivalent of 6-8 years of related experience in Quality Engineering.

PREFERRED QUALIFICATIONS:

• Experience with root cause analysis, design control, design transfer, Risk Management, and validation activities.
• ASQ Certified Quality Engineer certification.
• Analytical/Problem Solving Skills (e.g. DMAIC, statistical, risk analysis, engineering analysis)
• Writing and Communication Skills (e.g. write technical reports, present data analysis)
• Interpersonal Skills
• Service Orientation
• Working knowledge of FDA’s 21 CFR Part 820 Quality System Regulation, ISO 13485:2016 Medical Devices, and ISO 14971:2012 Risk Management.

COMPETENCIES:

• Avoids getting stuck in a "one right way" approach – remains open minded to new ideas.
• Proactively listens to internal /external customers and clarifies expectations.
• Role models Quality First by continuously improving on what matters most to customers.
• Promptly and effectively handles issues and problems.
• Actively develops a network to bring best solutions to the team or customer.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities. To request an accommodation, please contact your local HR department.

The salary for this role is between $104,300 – $208,500