Quality Assurance Engineer Jobs

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 Assurance Engineer is within our Cardiometabolic unit located at San Diego, CA. This role will be responsible for quality engineering activities, to monitor and measure compliance with the Quality System Regulation, Quality policies, FDA and ISO regulations as well as product quality and compliance objectives.

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

RESPONSIBILITIES:

• For both new products/processes and changes to existing products/processes develop verification and validation plans that assess if requirements are met. Oversee the execution
• Review/audit records, testing plans, risk analysis.
• Perform root cause analysis of product quality issues. Apply appropriate tools (e.g. statistics, fault tree analysis, etc.). Work with peers to develop corrective actions.
• Perform failure mode analysis on new or existing products. Working with peers, develop mitigations for failure modes, and verify the effectiveness of these mitigations.
• Participate on design transfer, design control and improvement project teams.
• Conduct Quality training as applicable.

of verification and validation plans. Write reports that summarize the verification and validation results.

• Other duties as assigned, according to the changing needs of the business
• Support the change control process by reviewing proposed changes, performing risk assessments, and assessing the adequacy of verifications and validations.
• 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; build productive internal/external working relationships
• Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
• Carries out duties in compliance with established business policies
• 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
• Support the complaint process by performing investigations
• Support the NC and CAPA processes by performing investigations and root cause analysis, determining action plans and driving the actions to closure.

MINIMUM QUALIFICATIONS | EDUCATION/EXPERIENCE:

• BS degree or equivalent.
• 2-4 years related experience in quality or engineering.

PREFERRED QUALIFICATIONS:

• Statistical tools including basic statistical inference, graphical methods, regression
• Analytical/Problem Solving Skills (e.g. statistical, risk analysis, engineering analysis)
• Writing and Communication Skills (e.g. write technical reports, present data analysis)
• Experience with root cause analysis, failure mode analysis, verification, and validation

• Working knowledge of FDA regulations

• An engineering or science background (medical device / diagnostics is preferred).

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 $65,200 – $130,400