Quality Engineer

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 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

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.

Our location in Temecula, CA currently has an opportunity for a Quality Engineer.

THIS POSITION IS AN ON-SITE DAILY REQUIRED ROLE.

The Opportunity

This position works out of our Temecula, CA location in the Abbott Vascular Division.  Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease.

  

What you’ll do:

Provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer.  Provide Process/Quality Engineering support to product development teams, helping to ensure development of highest quality new products.

The Quality Engineer is expected to assist in the identification and resolution of quality related issues. You'll have the opportunity to apply subject matter expertise, in an individual contributor role with limited supervision. Expected to provide quality engineering support to the site to ensure manufacturing/quality requirements are met and understand and elevate issues related to quality validations. Work with a team to establish and implement a dynamic structure that fosters and ensures consistent compliance to external laws, regulations, guidances and standards that affect the quality system. The team will develop and follow a process to implement a structure that will facilitate a consistent implementation of external quality system standards including leading activities for site inspection readiness. This structure will improve coordination between functions and increase the awareness and compliance of external requirements.

Core Job Responsibilities

• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
• Assist in the review and/or 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
• Lead the investigation, resolution and prevention of product and process non-conformances
• Manages monthly Quality Data Review and/or quarterly Management Review activities for the Site and ensures accurate information is provided at the site level
• Ensures compliance with FDA and global regulatory agency requirements for manufacturing site registrations and device listings
• Lead and Support all site announced and unannounced site inspections/audits from both internal and external agencies, including site preparation/inspection readiness.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• May be responsible for querying & bounding data to support implementation of complex & documenting release