Quality Engineer I

Mon-Fri - 12pm-9pm - mid shift

The Quality Engineer is responsible for maintaining quality and control of manufacturing processes and post-market performance of medical devices. Responsibilities include collaborating with internal and external stakeholders to achieve company objectives, leading technical root cause investigations, developing and executing risk-based decisions, resolving and documenting customer complaint and manufacturing investigations, and representing Quality in cross-functional projects.

Job Duties :

Develops and executes plans for quality and control to ensure manufacturing continuity and product conformance.

Leads investigations into production and customer-facing quality issues to identify root cause, implement corrective and preventative actions, and monitor effectiveness

Monitors and analyses product performance of medical devices using a statistical and risk-based approach. Considers any quality, compliance, customer, and business risks.

Performs hands-on troubleshooting of customer returned devices and manufacturing nonconformities and completes associated technical documentation

Develops tools to communicate complex technical problems and solutions to a variety of audiences within the organization

Proficient in project management, data analysis, root cause analysis, communication, and risk determination

Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies as pertaining to medical devices.

Minimum Requirements :

Bachelor's degree in Engineering

2 years of relevant experience in a regulated industry (FDA environment preferred)

Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO 13485 standard

• Pay and Benefits

The pay range for this position is $35.00 - $35.00 / 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 Irvine,CA.

• Application Deadline

This position is anticipated to close on Oct 8, 2025.

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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.