IT Quality Engineer

Description

This role is responsible for execution of the CAPA processes by owning the event occurrence, investigation, and documentation for any suspected policy, process, or procedure or production related system nonconformity. Responsibilities include: Leads the IT Compliance activities and strategy for specific CAPA (Corrective and Preventive Action) event evaluations, investigations, and resolution planning per established policies and procedures. Provides understanding and leadership of CAPA processes, System Life Cycle, BTS Quality System, validation and compliance processes/procedures to organization and stakeholders. Acts as a liaison and IT Compliance expert to assure successful investigations and corrective actions. Assembles and leads (virtual or onsite) CAPA CFT (cross-functional team) team with all needed parties/expertise to effectively and efficiently address assigned CAPA events. Exercises critical thinking to ask questions of discovery, confirm veracity of answers and locate information for CAPA record completion. Exercises Project management skills to drive for completion of CAPA events (assignment of action ownership, details, milestone dates) and ensures CAPA events are investigated and remediated according to schedule. Hold CFT members accountable for deliverables and create a sense of ownership and momentum to drive results. Monitor implementation plan and effectiveness check due dates and works with BTS IT owners to ensure implementations are completed on time. Applies technical writing and reasoning skills to author and/or approve documentation per policy and procedure to support CAPA activities. This includes evaluation, investigation, containment, resolution, implementation, and effectiveness checks in support of IT quality activities. Accountable for maintaining, reporting, and evolving the CAPA metric data for BTS, including developing management review metrics for upper management communications as needed. Escalates status, implementation, and effectiveness issues to CAPA management to communicate regular progress and mitigate quality system risk as needed.

Skills

CAPA, IT Systems Experience, Health Care, Life sciences, Trackwise

Top Skills Details

CAPA,IT Systems Experience,Health Care,Life sciences

Additional Skills & Qualifications

Candidates should posses good organization, project management and documentation skills. The IT Quality Engineer will work with Systems SME's to compile information, create records and documentation to be reviewed by Auditors. Must have good critical thinking skills and able to synthesize information into a consumable story for an outside auditor to understand. Prior experience with ISO 13458, IEC 62304 would be a plus.

Experience Level

Intermediate Level
Job Type & Location
This is a Contract position based out of Abbott Park, IL.
Pay and Benefits
The pay range for this position is $35.00 - $40.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Abbott Park,IL.
Application Deadline
This position is anticipated to close on Jan 20, 2026.
>About TEKsystems:
We're partners in transformation. We help clients activate ideas and solutions to take advantage of a new world of opportunity. We are a team of 80,000 strong, working with over 6,000 clients, including 80% of the Fortune 500, across North America, Europe and Asia. As an industry leader in Full-Stack Technology Services, Talent Services, and real-world application, we work with progressive leaders to drive change. That's the power of true partnership. TEKsystems is an Allegis Group company.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

About TEKsystems and TEKsystems Global Services

We're a leading provider of business and technology services. We accelerate business transformation for our customers. Our expertise in strategy, design, execution and operations unlocks business value through a range of solutions. We're a team of 80,000 strong, working with over 6,000 customers, including 80% of the Fortune 500 across North America, Europe and Asia, who partner with us for our scale, full-stack capabilities and speed. We're strategic thinkers, hands-on collaborators, helping customers capitalize on change and master the momentum of technology. We're building tomorrow by delivering business outcomes and making positive impacts in our global communities. TEKsystems and TEKsystems Global Services are Allegis Group companies. Learn more at TEKsystems.com.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.