Principal Engineer

Pacer Group; Draper (UT); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401(k)

Job summary

Pacer Group is seeking a senior CAPA leader to own high-complexity CAPA processing and accelerate remediation across the site portfolio.

You will coach CAPA personnel, review investigations and action plans, ensure documentation integrity, and apply risk-based decisions impacting the QMS, product, and process. FDA inspections experience preferred.

Qualifications

• 8-10 years experience required.

Responsibilities

• Lead and own CAPA processing for high-complexity issues across the site portfolio.
• Provide guidance and day-to-day technical direction to CAPA personnel, including contract Sr. Quality Engineers, reviewing investigations and action plans.

Skills

CAPA management

Quality leadership

Risk assessment

Documentation control

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.

Responsibilities:

• 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.

BENEFITS

• Medical
• Dental
• Vision
• 401(k)

EEOC Compliance:

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment.

DISCLAIMER

AI Usage Policy: Pacer Group uses AI to assist in screening applications. Final hiring decisions are made by human recruiters based on qualifications and experience.