Principal Engineer

TEKsystems; Draper (UT); Presencial; USD 90 000 - 103 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical

Dental & Vision

401(k) Retirement Plan

Life Insurance

Short and long-term disability

HSA (Health Spending Account)

Transportation benefits

Employee Assistance Program

PTO / Vacation

Resumo da oferta

TEKsystems is seeking an Expert Level CAPA lead for a contract role based in Draper, UT, onsite. You will own high-complexity CAPAs, provide technical direction, and coach the CAPA team while aligning with the broader quality system and audit readiness.

You will prepare board materials, review investigations, and ensure documentation compliance across CAPA records. The role involves supporting FDA inspections, Notified Body, and customer audits as needed.

Qualificações

• Expert-level CAPA experience and leadership in quality systems.
• Solid knowledge of ISO 13485 and 21 CFR 820/QMSR.
• Experience guiding investigations, action plans, and effectiveness checks.

Responsabilidades

• Own designated CAPAs with high complexity and visibility.
• Coach CAPA personnel and balance workload across the team.
• Prepare CAPA Review Board materials and present portfolio status.

Conhecimentos

CAPA management

QMS knowledge

FDA inspections

Descrição da oferta de emprego

Description

Take personal ownership and processing of designated high-complexity, high-visibility CAPAs while driving overall CAPA process acceleration across the site portfolio. Provide guidance, coaching, and day-to-day technical direction to additional CAPA personnel including the contract Sr. Quality Engineers balancing workload and reviewing investigations, action plans, and effectiveness checks prior to routing. Support the CAPA Chair: prepare CAPA Review Board materials, pre-screen records for board readiness, present portfolio status and aging, and follow through on board decisions and commitments. Support Quality System updates and modifications, leading or approving revisions to CAPA procedures, templates, and training content, and performing gap analysis against ISO 13485, 21 CFR 820/QMSR, and MDSAP expectations. Ensure documentation compliance across the CAPA subsystem record integrity, traceability, and audit readiness of all closed and in-flight records. Apply risk-based decision-making to determine the impact of systemic nonconformities on the QMS, product, and process, and to set the appropriate scope and depth of corrective action. Connect CAPA outcomes to the broader quality system complaints, NCs, internal/external audit findings, risk management, and Management Review to identify and close systemic gaps. Preferred: Act as SME during FDA inspections, Notified Body, and customer audits: defend CAPA records, draft and negotiate audit responses, and manage follow-up commitments to closure.

Experience Level

Expert Level

Job Type & Location

This is a Contract position based out of Draper, UT.

Pay and Benefits

The pay range for this position is $65.00 - $75.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

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 Draper,UT.

Application Deadline

This position is anticipated to close on Oct 19, 2026.

Equal Opportunity & Diversity Statements

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.

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.

San Francisco Fair Chance Ordinance

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI)

We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.