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Senior Validation Quality Specialist

3 weeks ago

Austin, Texas, United States Abbott Full time
About the Role

The Senior Validation Quality Engineer will be responsible for providing quality support and oversight on product, process, and equipment related changes and implementations (validation & change control). This includes ensuring that facilities, utilities, and equipment used in the support of the Quality System are validated and maintained in compliance with regulatory and Abbott requirements.

Key Responsibilities:

  • Provide quality support and oversight (approval) of process and equipment validation and change control records and activities.
  • Ensure consistent deliver of high-quality documents, processes, products, and processes.
  • Review documentation for accuracy, clarity, consistency, completeness, and compliance to internal and external requirements.

What You'll Do

As a Senior Validation Quality Engineer, you will work independently with objectives given by the Quality Manager. You will plan and coordinate your own work according to higher-level project schedules. You will also support the investigation, resolution, and prevention of product and process nonconformances, CAPA investigations, or other quality system records.

Requirements

  • Bachelor's Degree in Engineering or Technical Field or an equivalent combination of education and work experience.
  • Minimum 5 years experience in medical device/pharmaceutical manufacturing.
  • Demonstrated supervisory experience preferred.
  • Validation experience and demonstrated use of Quality tools/methodologies.
  • Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.

Estimated Salary: $103,500-$143,000 per year

About Us

At Abbott, we are 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.