Senior Specialist IT Quality

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 115,000 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.

The Opportunity:  

The Senior Specialist - IT Quality provides quality oversight and compliance leadership for regulated data center facilities, utilities, and equipment supporting healthcare and GxP-relevant IT operations. This role ensures that data center physical infrastructure and supporting systems are operated, maintained, and controlled in compliance with applicable regulatory requirements, internal quality standards, and industry best practices.

The position partners closely with Facilities Engineering, Data Center Operations, IT Infrastructure, Quality, and Safety teams to ensure inspection readiness, lifecycle control, and sustained reliability of critical data center environments.

Primary Job Function

Individual contributor with comprehensive knowledge in specific areas and performs quality assurance support /project work related to:

•             Data center facilities, utilities, and equipment

•             Compliance initiatives

•             Validations

•             Supplier Quality activities

•             Internal / supplier audits CAPA system investigation, confirmation, or verification.

What You’ll Work On:

Facilities, Utilities, and Equipment:

• Ensure that data center facilities, utilities, and equipment comply with applicable regulatory, corporate, and quality requirements.
• Ensure appropriate qualifications, documentation, and change control for regulated facilities and infrastructure.

• Oversee commissioning, qualification, and requalification activities for data center infrastructure and equipment.
• Review and approve lifecycle documentation, including:
  • Installation, operational, and performance qualification protocols
  • Maintenance and calibration records
• Ensure infrastructure remains in a validated and compliant state throughout its operational lifecycle.

• Ensure production and process controls are established, implemented, and maintained for data center facilities, utilities, and equipment supporting regulated IT operations.

• Provide quality oversight and approval for changes impacting regulated data center facilities, utilities, or equipment.

Quality Compliance

• Ensure facilities- and equipment-related documentation is complete, accurate, and inspection-ready.
• Review nonconformances, CAPA, deviations, incidents, excursions, and infrastructure-related events impacting environmental or system integrity.
• Ensure timely investigations, root cause analyses, CAPA development, and effectiveness checks.

• Support and participate in internal audits, supplier audits, and regulatory inspections involving data center infrastructure.
• Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Perform work using standard methodologies, processes and tools to ensure IT Compliance.
• Responsible for implementing and maintaining the effectiveness of the quality system.
• Responsible for assessing risk and applying risk-based approach strategies without compromising compliance.
• Perform Quality function related to process improvements, metrics collection and analysis, and adherence to defined Abbott practices.
• Create, review and approve quality documentation in support of quality activities.
• Establish project tasks and timelines and is held accountable to them.
• Identify potential process improvements.

Minimum Requirements & Qualifications:

Required Qualifications:

• 3+ years of experience in a regulated quality systems environment, preferably within:
  • Healthcare, pharmaceutical, biotechnology, or medical device industries
  • Data center operations, facilities engineering, or critical infrastructure support
• Demonstrated experience in facilities, utilities, or equipment qualification and compliance.
• Strong analytical, judgment, and consultative skills with the ability to work across Facilities, IT, and Quality organizations.
• Knowledge of regulations and standards that affect the health care industry.

Minimum Education Required

• Bachelor’s degree or equivalent experience

Position Accountability & Scope

• Excellent analytical, judgment and consultative capabilities and communication skills and the ability to work with both IT management and staff. 
• Accountable for global compliance with IT policy and procedures that have specific responsibility in the area of quality, documentation and adherence to global regulations.
• Exercises significant latitude in determining objectives, methods, and solutions to maintain compliance.
• Decisions directly impact regulatory readiness, infrastructure reliability, and continuity of regulated IT services.

Supervisory Responsibilities

• None.

Misc: This is an onsite role at Abbott location in IL. This is not a remote role/opportunity.

Apply Now

• Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com
• Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
• Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.

     

The base pay for this position is

$78,000.00 – $156,000.00

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Information Risk & Quality Assurance

     

DIVISION:

BTS Business Technology Services

        

LOCATION:

United States > Waukegan : J46

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 5 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

     

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

     

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

     

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf