Principal Engineer

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.

Expert Level

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

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)

This is a fully onsite position in Draper,UT.

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

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.

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.

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.

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.