Quality Assurance Engineer

Quality Assurance Engineer

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

The Quality Assurance Engineer position is within our CMI Unit located in Pomona, California. This role plays a critical part in ensuring product and process quality, compliance, and continuous improvement across operations.

Key Responsibilities:

• Lead quality engineering activities related to:
  • Product and process changes
  • Product/process quality issues
  • Compliance concerns
• Partner with operations to drive process improvement and continuous improvement initiatives.
• Conduct process audits within operational areas to ensure adherence to quality standards.
• Support the development of new products, including participation in design control activities.

WHAT YOU’LL DO

• Actively partner with operations to perform process audits to identify and implement improvement initiatives as required.
• Identify, review, and implement effective process control systems to support the development, qualification, and/or on-going manufacturing of products to meet or exceed internal and external requirements.
• Support the change control process by reviewing proposed changes, performing risk assessments, and assessing the adequacy of verifications and validations.
• Perform Risk Assessments, as required, across functions, including FMEA, change management, and issue investigation / resolution.
• Lead in the review and/or implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
• Assist in the review, development, and execution of streamlined business systems which effectively identify and resolve quality issues.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• 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.  Ensure all reasonable failure modes are identified.  Working with peers, develop mitigations for failure modes, and verify the effectiveness of these mitigations.
• Work on problems of limited scope.
• Lead the investigation, resolution and prevention of product and process non-conformances.
• Lead process control and monitoring of CTQ parameters and specifications as required.
• Appropriately document experiment plans and results, including protocol and report writing/reviews.
• Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member).
• Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.
• Coordinates for both new products/processes and changes to existing products/processes develop verification and validation plans that assess if requirements are met. 
• 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.
• Carries out duties in compliance with established business policies.
• Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
• Perform other duties and projects as assigned.

Required Qualifications