Quality Engineer: Process Improvement & Validation Lead

Employbridge; Coon Rapids (MN); On-site; USD 95,000 - 135,000; Full time

Job summary

Employbridge in Minnesota seeks a Quality Assurance professional to develop, implement, maintain, and improve QA processes. You will use data analysis to better understand quality reporting measures and drive process improvements across manufacturing.

Responsibilities include leading validations (IQ/OQ/PQ), PFMEA, GR&R, SPC, NCR/CAPA, audits, change control, and collaboration with production, suppliers, and customers to deliver higher quality outcomes.

Qualifications

• Bachelor's degree in Engineering or related field.
• 2+ years of Quality Engineering experience or 5+ years for senior level.
• Experience with quality tools including PFMEA, GR&R, SPC, NCR, and CAPA.
• Knowledge of ISO-regulated environments, preferably ISO 13485.

Responsibilities

• Develop and improve manufacturing processes and quality plans.
• Lead product, process, and equipment validations (IQ/OQ/PQ).
• Perform PFMEA, GR&R, SPC, and process capability studies.
• Manage NCRs, CAPAs, customer complaints, and supplier corrective actions.
• Support audits, change management, and quality documentation.
• Partner with production, customers, and suppliers to drive quality improvements.

Skills

Quality mindset

Data analysis

Problem solving

Education

Bachelor's degree in Engineering

Tools

PFMEA

GR&R

SPC

NCR

CAPA

Job description

Employbridge in Minnesota seeks a Quality Assurance professional to develop, implement, maintain, and improve QA processes. You will use data analysis to better understand quality reporting measures and drive process improvements across manufacturing.

Responsibilities include leading validations (IQ/OQ/PQ), PFMEA, GR&R, SPC, NCR/CAPA, audits, change control, and collaboration with production, suppliers, and customers to deliver higher quality outcomes.