Quality Engineer

Job overview

The Quality Engineer role is onsite in Latrobe, PA. Compensation is $75,000–$85,000 per year. The position supports maintenance of the Quality Management System for compliance with ISO 13485, regulatory bodies, and customer agreements. The engineer defines requirements for new products, monitors production quality, and maintains quality documentation. Through validation planning, risk assessment, and investigation of nonconformances, the role helps ensure products meet customer and regulatory requirements.

What you'll do

• Evaluate specifications, requirements, and design documents
• develop validation plans using IQ/OQ/PQ structure
• plan and coordinate validation activities
• complete validation documentation
• conduct FMEAs and risk assessments
• support root-cause investigations and corrective actions
• use quality tools and data analysis to identify improvements
• support new product development and production.

What we're looking for

Skills & competencies

quality engineer

latrobe pa

system one

iso 13485

quality management system

validation

iq oq pq

fmea

risk assessment

root-cause analysis

corrective actions

$75,000–$85,000/year

onsite

40 hours

Work arrangement

• Weekend coverage required

Benefits & perks

• Eligible employees may access medical, dental, vision, spending accounts, life insurance, voluntary plans, and a 401(k) plan.

About the employer

System One is hiring for this role. Industry: Engineering Services. Sector: 54.