Senior Validation 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 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.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position is an onsite opportunity in the Abbott Diabetes Care Division. We are helping people with Diabetes lead healthier, happier lives.   As a global leader in diabetes care, Abbott is constantly working to deliver the highest quality products and unwavering support to our customers.  Consistent and accurate glucose monitoring is the foundation of any diabetes management plan, so we’re committed to continuous improvement in the way patients and professionals measure, track and analyze glucose levels.

This is an onsite daily opportunity

What You’ll Do

As the Senior Quality Engineer, you will be responsible for performing quality oversight & approval of validations, change controls, records, & projects to ensure consistent deliver of high quality documents, processes, products, and processes.

MAIN PURPOSE OF ROLE
This position is responsible for providing quality support and oversight on product, process, and equipment related changes and implementations (validation & change control). Specifically,

• Provide quality support and oversight (approval) of process and equipment validation and change control records and activities,
• Ensure that facilities, utilities, and equipment (FUE) used in the support of the Quality System are validated and maintained in compliance with regulatory and Abbott requirements,
• Review documentation (including but not limited to validation records/reports, change control records, periodic reviews, etc.) for accuracy, clarity, consistency, completeness, and compliance,
• Plan and complete assignments with a wide degree of difficulty while maintaining milestones established in the project schedule,
• Analyze data, procedures, and requirements to ensure quality and compliance,
• Collaborate with alternate functional teams (including but not limited to engineering, operations, regulatory, program management, and other quality teams) to ensure consideration is given to financial and business outcomes when making quality decisions,
• Coordinate activities across multiple project groups,
• Accept ownership and responsibility for decisions,
• Effectively engage with team members within Abbott and third party manufacturer (TPM) teams, and
• Provide guidance, coaching, and training to various functions and colleagues.

MAIN RESPONSIBILITIES

• Participate in the development or modification of validation packages and deliverables, including assessments, plans, requirements, and protocols.
• Report unexpected events or issues which occur during validation to project team and management.
• Apply sound, systematic problem-solving methodologies in identifying, investigating, assessing impact, and resolving unexpected events or issues which occur during validation.
• Perform quality oversight & approval of equipment, process, and validation documentation and change control records (e.g. pFMEAs, URSes protocols, report