Manufacturing Engineer - CAPA & Quality Systems Lead

Intellectt Inc; Draper (UT); On-site; USD 90,000 - 130,000; Full time

Job summary

Intellectt Inc. is seeking a CAPA specialist to take ownership of high-complexity CAPAs and drive acceleration across site portfolios. You will guide CAPA personnel, support CAPA Chair with board materials, and ensure documentation integrity and audit readiness across the CAPA subsystem.

The role involves risk-based decision-making on systemic nonconformities and alignment with the broader quality system, including inspections and customer audits when needed.

Qualifications

• Bachelor's degree in engineering is required.

Responsibilities

• Take ownership of designated CAPAs and drive process acceleration.
• Provide guidance and day-to-day direction to CAPA personnel, including contract Sr. Quality Engineers.
• Prepare CAPA Review Board materials and track aging and action closure.
• Lead revisions to CAPA procedures, templates, and training; perform gap analysis against ISO 13485 and 21 CFR 820/QMSR.

Skills

CAPA management

Quality system

Coaching & mentoring

Regulatory inspections

Education

Bachelor's degree in engineering

Tools

CAPA templates

QMS alignment

Job description

Intellectt Inc. is seeking a CAPA specialist to take ownership of high-complexity CAPAs and drive acceleration across site portfolios. You will guide CAPA personnel, support CAPA Chair with board materials, and ensure documentation integrity and audit readiness across the CAPA subsystem.

The role involves risk-based decision-making on systemic nonconformities and alignment with the broader quality system, including inspections and customer audits when needed.