Quality Engineer: Validation, Risk & Root-Cause Expert

Technimark; Latrobe (Westmoreland County); On-site; USD 60,000 - 75,000; Full time

Job summary

Technimark in Latrobe, PA is seeking a Quality Engineer to evaluate specifications, design documents, and customer needs to support compliant product development and production. The role focuses on IQ/OQ/PQ validation planning, risk assessment, FMEA, and continuous improvement using quality tools to prevent defects and meet regulatory requirements.

Candidates should have a college degree or equivalent QE experience and be proficient with data analysis and quality tools to drive root-cause

Qualifications

• College Degree or 4+ years QE experience.
• Experience with quality tools and data analysis.
• Knowledge of regulatory requirements and GMP/ISO is a plus.

Responsibilities

• Evaluate specifications and design documents to provide feedback.
• Develop validation plans using IQ/OQ/PQ structures.
• Plan and coordinate validation activities to meet requirements.
• Ensure validation documentation is completed per requirements.
• Develop and execute FMEAs and risk assessments.
• Support root-cause investigations and corrective actions.
• Apply quality tools to identify improvements and solve problems.
• Support new product development and production to meet customer expectations.

Skills

Data analysis

Quality tools

Education

College Degree

Tools

IQ/OQ/PQ

FMEA

Quality risk assessment tools

Job description

Technimark in Latrobe, PA is seeking a Quality Engineer to evaluate specifications, design documents, and customer needs to support compliant product development and production. The role focuses on IQ/OQ/PQ validation planning, risk assessment, FMEA, and continuous improvement using quality tools to prevent defects and meet regulatory requirements.

Candidates should have a college degree or equivalent QE experience and be proficient with data analysis and quality tools to drive root-cause