Senior Quality Engineer - Manufacturing & CAPA Lead

Regulatory Toolkit; Salt Lake City (UT); On-site; USD 95,000 - 125,000; Full time

Job summary

Regulatory Jobs in Salt Lake City, UT, seeks a Manufacturing Quality Engineer III to serve as an advanced quality engineer and technical lead. The role directs complex investigations, CAPA development, and risk-based process control, while mentoring junior QE staff and driving defect-reduction programs.

You will lead multi-functional efforts across quality systems, validate improvements, and ensure closure readiness with strong data-driven decisions and process-control health focus.

Qualifications

• Requires a bachelor’s degree in Engineering, Science, Quality, Technology, or related field.
• 4–7 years of quality engineering/manufacturing quality experience in regulated settings.
• Green Belt certification or higher preferred; ASQ CQE or equivalent preferred.

Responsibilities

• Lead complex NCMRs with recurrence, high cost, multi-lot impact, or unclear root causes.
• Define investigation strategy, evidence, containment, risk, and escalation for complex records.
• Coach QE I/II on NCMR, complaint, and CAPA records for quality and closure readiness.
• Support CAPA Owners with investigations, root causes, actions, evidence, and effectiveness checks.
• Lead cross-functional continuous-improvement projects tied to NCMR and CAPA reductions.
• Mentor QE staff on investigations, CAPA thinking, risk-based disposition, and data analysis.

Skills

NCMR leadership

CAPA investigations

Root-cause analysis

Kaizen facilitation

DMAIC

A3/PDCA

Quality data analysis

Cross-functional mentoring

Education

Bachelors in Engineering/Science/Quality/Technology

Green Belt certification (preferred)

ASQ CQE or equivalent (preferred)

Tools

SPC

PFMEA

Control plans

Job description

Regulatory Jobs in Salt Lake City, UT, seeks a Manufacturing Quality Engineer III to serve as an advanced quality engineer and technical lead. The role directs complex investigations, CAPA development, and risk-based process control, while mentoring junior QE staff and driving defect-reduction programs.

You will lead multi-functional efforts across quality systems, validate improvements, and ensure closure readiness with strong data-driven decisions and process-control health focus.