Quality Assurance Expert

6 days ago

Austin, Texas, United States Abbott Laboratories Full time
About Abbott Laboratories

Abbott Laboratories is a global healthcare leader dedicated to delivering life-changing technologies that improve people's lives at all stages of life. Our diverse portfolio spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.

We have a strong presence in over 160 countries, serving millions of patients worldwide. Our talented team of over 114,000 colleagues is passionate about making a meaningful impact on people's health and well-being.

Job Description

This role offers an exciting opportunity to join our Quality Assurance team as a Senior Validation Quality Engineer. You will play a vital part in ensuring the highest quality standards are met in our manufacturing processes.

In this position, you will be responsible for providing quality oversight and approval of validations, change controls, records, and projects to ensure consistent delivery of high-quality documents, processes, and products.

You will work closely with cross-functional teams to ensure quality and compliance requirements are considered during activities. This includes reviewing documentation for accuracy, clarity, consistency, completeness, and compliance with internal and external requirements.

As a Senior Quality Engineer, you will drive strategy for facilities, utilities, and equipment (FUE) validation for new or changing products, processes, facilities, equipment, etc. You will also ensure that appropriate procedures, controls, and recovery plans are incorporated into equipment, system, process, and/or product implementations/changes.

Key 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, reports, SOPs, work instructions, process flow diagrams, ECs, etc.)
Requirements

To be successful in this role, you will need:

  • A Bachelor's Degree in Engineering or Technical Field or 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.
  • Solid communication (written and oral) and interpersonal skills.
  • Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
Benefits

We offer a competitive compensation package, including:

  • Base pay: $72,700.00 – $145,300.00 per annum.
  • Tuition reimbursement and education assistance programs.
  • Opportunities for professional growth and development.
  • A comprehensive benefits package, including medical, dental, vision, wellness, and occupational health programs.
  • Paid time off and holidays.
  • A 401(k) retirement savings plan with a generous company match.

Note: The salary range may vary based on specific locations.

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