TEKsystems · 9 hours ago
IT Quality Engineer
TEKsystems is a leading provider of business and technology services, and they are seeking an IT Quality Engineer responsible for executing CAPA processes and leading IT Compliance activities. The role involves managing investigations, documentation, and ensuring timely completion of CAPA events while collaborating with cross-functional teams.
Information Technology
Responsibilities
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
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
Qualification
Required
CAPA
IT Systems Experience
Health Care
Life sciences
Good organization skills
Project management skills
Documentation skills
Good critical thinking skills
Ability to synthesize information into a consumable story for an outside auditor to understand
Preferred
Prior experience with ISO 13458
Prior experience with IEC 62304
Benefits
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)
Company
TEKsystems
At TEKsystems, they understand people. Every year they deploy over 80,000 IT professionals at 6,000 client sites across North America,
H1B Sponsorship
TEKsystems has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (46)
2024 (52)
2023 (33)
2022 (22)
2021 (36)
2020 (53)
Funding
Current Stage
Late StageRecent News
2025-11-19
2025-10-29
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