Quality Engineer

United Pharma; Kentucky; On-site; USD 75,000 - 110,000; Full time

Job summary

United Pharma seeks an experienced Quality Engineer to support Manufacturing Quality Operations in a medical device environment. The role focuses on reviewing technical documentation, evaluating manufacturing and validation data, and ensuring compliance with quality and regulatory requirements.

The ideal candidate will have strong analytical skills, experience with Design Controls, and the ability to identify documentation gaps and drive process improvements.

Qualifications

• Minimum 5+ years of Quality Engineering experience in the medical device industry.
• Strong knowledge of Design Controls and manufacturing quality processes.
• Experience reviewing validation documentation and technical reports.
• Proficiency in statistical analysis and data trending.
• Excellent technical writing and problem-solving skills.

Responsibilities

• Review validation, characterization, and manufacturing documentation for technical accuracy and regulatory compliance.
• Evaluate statistical analyses, process capability studies, CPPs, and technical reports to identify data trends and documentation gaps.
• Assess validation documentation, including IQ/OQ/PQ, PPQ, FAT/SAT, URS, PFMEA, Control Plans, DMRs, and engineering documents.
• Support equipment qualification activities and remediation efforts to strengthen manufacturing processes and quality documentation.
• Partner with cross-functional teams to resolve quality issues and improve technical justifications.
• Ensure documentation is inspection-ready and compliant with quality standards.

Skills

Quality Engineering

Design Controls

Statistical Analysis

Documentation Review

Problem Solving

Job description

We are seeking an experienced Quality Engineer to support Manufacturing Quality Operations within a medical device environment. This role focuses on reviewing technical documentation, evaluating manufacturing and validation data, and ensuring compliance with quality and regulatory requirements. The ideal candidate will have strong analytical skills, experience with Design Controls, and the ability to identify documentation gaps and drive process improvements.

Key Responsibilities

• Review validation, characterization, and manufacturing documentation for technical accuracy and regulatory compliance.
• Evaluate statistical analyses, process capability studies, CPPs, and technical reports to identify data trends and documentation gaps.
• Assess validation documentation, including IQ/OQ/PQ, PPQ, FAT/SAT, URS, PFMEA, Control Plans, DMRs, and engineering documents.
• Support equipment qualification activities and remediation efforts to strengthen manufacturing processes and quality documentation.
• Partner with cross-functional teams to resolve quality issues and improve technical justifications.
• Ensure documentation is inspection-ready and compliant with quality standards.

Required Qualifications

• 5+ years of Quality Engineering experience in the medical device industry.
• Strong understanding of Design Controls and manufacturing quality processes.
• Experience reviewing validation documentation and technical reports.
• Knowledge of statistical analysis, process capability, and data trending.
• Excellent technical writing, documentation review, and problem-solving skills.