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Quality Assurance Validation Engineer

2 months ago

Casa Grande, Arizona, United States Abbott Full time

About Abbott

Abbott is a leading global healthcare organization dedicated to enhancing the quality of life for individuals at every stage of their journey. Our extensive portfolio includes innovative technologies across various healthcare sectors, encompassing diagnostics, medical devices, nutrition, and branded generic medicines. With a workforce of 114,000 professionals, we serve communities in over 160 countries.

Position Overview

The role of the Quality Assurance Validation Engineer is pivotal within our organization, particularly in the Nutrition division. This division is focused on developing scientifically-backed nutritional products that cater to individuals of all ages, from infants to adults. Our renowned brands are trusted by millions globally to provide essential nutrients for healthier living.

Why Join Abbott?

At Abbott, you will engage in meaningful work, pursue personal and professional growth, and enjoy a supportive environment that values your individuality. Benefits include:

  • Access to clean, well-maintained, and climate-controlled production areas
  • Comprehensive training and career advancement opportunities, including onboarding programs and tuition assistance
  • Competitive compensation and financial security through incentives and retirement plans
  • Health and wellness programs that encompass medical, dental, vision, and occupational health services, with benefits commencing on your first day
  • Generous vacation policy including 120 hours of accrued vacation, personal days, and paid holidays
  • Retiree healthcare options
  • Robust 401(k) retirement savings plan with a substantial company match
  • Tuition reimbursement and educational benefits to support your academic goals
  • A company recognized globally as a top employer and a leader in workplace diversity
  • A stable organization with a strong financial track record and community engagement

Key Responsibilities

  • Develop and oversee the Validation Management Plan (VMP)
  • Collaborate with cross-functional teams to ensure adherence to validation regulations
  • Review and endorse validation protocols and documentation
  • Maintain comprehensive validation records
  • Lead Design Qualification processes, including System Impact Assessments (SIA) and Failure Mode Effects Analysis (FMEA)
  • Formulate and execute validation protocols and procedures
  • Conduct risk assessments to identify compliance gaps
  • Ensure all systems and equipment align with regulatory standards
  • Document validation activities meticulously
  • Perform regular audits to maintain compliance
  • Provide training on validation processes to team members
  • Investigate and resolve validation-related challenges
  • Prepare and present validation findings to management
  • Stay informed on industry standards and regulatory updates
  • Coordinate with external auditors as necessary
  • Manage validation project timelines
  • Engage in continuous improvement initiatives
  • Ensure proper calibration of validation equipment
  • Assist in formulating quality assurance policies

Qualifications

  • A Bachelor's degree in Life Science, Engineering, or a related field is essential
  • A minimum of 5 years experience in Quality, Validation, Engineering, or a related domain, preferably within the food industry or sectors with similar regulatory requirements

Abbott is committed to fostering a diverse workforce and providing equal employment opportunities. We welcome and encourage applications from individuals of all backgrounds.