Quality Engineer

Novozen Healthcare LLC; Kentucky; On-site; USD 85,000 - 105,000; Full time

Job summary

Novozen Healthcare LLC in Kentucky is seeking a Quality Engineer – Manufacturing Quality to support manufacturing quality operations and drive robust quality systems. You will review validation and process data, ensure documentation is complete and compliant, and collaborate with engineering, manufacturing, and validation teams to resolve gaps.

The role requires strong technical writing, analytical skills, and a solid understanding of Design Controls and regulatory requirements to ensure

Qualifications

• 5+ years of quality engineering experience in medical devices.
• Strong design controls knowledge and relationship of design to manufacture.
• Experience reviewing technical documentation for gaps.
• Excellent technical writing and analytical skills.
• Ability to evaluate statistics, process capability, and data trends.
• Experience supporting manufacturing quality, remediation, and quality systems.
• Strong understanding of medical device regulatory requirements.
• Excellent critical-thinking and problem-solving abilities.
• Strong communication across engineering, manufacturing, and validation teams.

Responsibilities

• Review validation, characterization, manufacturing, and quality documentation for accuracy and compliance.
• Evaluate statistical analyses, process capability studies, data trends, and reports.
• Review characterization and process studies for data-supported conclusions.
• Assess acceptance criteria, test results, and conclusions.
• Identify documentation gaps and support remediation activities.
• Partner with cross-functional teams to resolve gaps.
• Provide technical comments to improve reports, protocols, procedures.
• Support equipment qualification activities and review related deliverables.
• Ensure documentation is complete, traceable, and inspection-ready.

Skills

Quality engineering

Documentation review

Statistical analysis

Problem solving

Cross-functional teamwork

Job description

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.

Primary Responsibilities

• 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.

Required Qualifications

• 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.