Quality Engineer

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

Responsibilities

1. Evaluate specification, requirements, and design documents to provide prompt and valuable feedback to internal and external customers.
2. Develop detailed and well-structured validation plans using IQ OQ PQ structure.
3. Estimate, prioritize, plan and coordinate validation activities to ensure conformance to regulations, internal requirements and customer requirements.
4. Ensure all validation documentation completed per requirements.
5. Develop and execute FMEAs and risk assessments with internal and external teams as needed.
6. Support investigation of root cause of non-conformances and corrective actions.
7. Use quality tools to analyze and identify areas for improvements and problem solving techniques.
8. Support new product development and production to ensure that the product meets customer expectations.

Qualifications

• College Degree or 4+ years QE experience
• Quality Tools and Data Analysis

Equal Opportunity Employer

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