Principal Engineer

Ultimate Staffing; Draper (UT); On-site; USD 120,000 - 180,000; Full time

Job summary

Ultimate Staffing in Utah seeks an experienced CAPA leader to own high-risk CAPAs, accelerate the CAPA process, and ensure rigorous documentation and audit readiness.

You will guide CAPA personnel, prepare Review Board materials, and drive risk-based decisions, including responses for FDA inspections and Notified Bodies, while aligning with ISO 13485, 21 CFR 820 and MDSAP.

Qualifications

• 8–10 years experience in CAPA/quality roles.
• Experience with ISO 13485, 21 CFR 820/QMSR, and MDSAP.
• Strong leadership and coaching skills for CAPA personnel.

Responsibilities

• Take ownership of designated high-complexity CAPAs and drive process acceleration.
• Provide guidance and day-to-day technical direction to CAPA staff and contract Sr. Quality Engineers.
• Support CAPA Chair with board materials, aging, and follow-through on decisions.
• Lead updates to CAPA procedures, templates, training content, and perform gap analyses.
• Ensure documentation compliance, traceability, and audit readiness of all records.
• Apply risk-based decisions on systemic nonconformities and determine action scope.
• Link CAPA outcomes to complaints, NCs, audits, risk management, and management review.
• Act as SME during FDA inspections, Notified Body audits, and customer audits; draft responses.

Skills

CAPA management

Quality systems

FDA inspections

Risk management

Audit readiness

Documentation

GxP compliance

Education

Bachelor's degree in a relevant field

Job 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.

Education/Experience:

• 8-10 years experience required.

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, Los Angeles County Fair Chance Ordinance, and San Francisco Fair Chance Ordinance.