Quality Engineer

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.

• 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.

• 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.