Quality Engineer

Quality Engineer – Manufacturing Quality Position Summary

Our medical device client is seeking an experienced Quality Engineer to support Manufacturing Quality Operations. This role will provide exposure to equipment qualification and validation activities; however, this is not a traditional Validation Engineer position.

• Review validation, characterization, manufacturing, and quality documentation for technical accuracy, completeness, consistency, and regulatory compliance.
• Evaluate statistical analyses, process capability studies, data trends, and technical reports to identify abnormalities, inconsistencies, unsupported conclusions, and documentation gaps.
• Review characterization and process studies to ensure equipment and manufacturing processes are adequately supported by objective data.
• Assess acceptance criteria, test results, and technical conclusions to determine whether they are scientifically and technically justified.
• Identify documentation deficiencies and support remediation activities to strengthen manufacturing processes and quality systems.
• Partner with Engineering, Manufacturing, Validation, Quality, and other cross-functional teams to resolve technical and documentation gaps.
• Provide detailed technical comments and recommendations to improve reports, protocols, procedures, and supporting documentation.
• Support equipment qualification activities as needed, including review of qualification protocols, reports, and associated deliverables.
• Ensure documentation is complete, traceable, technically sound, and inspection-ready.

• 5+ years of Quality Engineering experience within the medical device industry.
• Strong understanding of Design Controls and the relationship between design requirements and manufacturing processes.
• Demonstrated experience reviewing technical documentation and identifying quality, technical, or regulatory gaps.
• Strong technical writing, documentation review, and analytical skills.
• Ability to evaluate statistical analyses, process capability studies, data trends, and technical conclusions.
• Experience supporting manufacturing quality, process improvement, remediation, and/or quality system activities.
• Strong understanding of medical device quality and regulatory requirements.
• Excellent critical-thinking and problem-solving skills.
• Ability to ask challenging technical questions, evaluate evidence objectively, and defend well-supported conclusions.
• Strong communication and collaboration skills with the ability to work effectively across Engineering, Manufacturing, Quality, and Validation teams.