Quality engineer

Fusion Life Sciences; Cincinnati (OH); On-site; USD 90,000 - 120,000; Full time

Job summary

Fusion Life Sciences is seeking a Quality Engineer (Medical Devices) in Cincinnati, OH, onsite. The role focuses on evaluating documentation, data analyses, and strengthening manufacturing quality documentation. Strong writing and QC background are essential.

The ideal candidate will review validation and characterization reports, ensure compliance, and support equipment qualification and remediation efforts across cross-functional teams. Start early September with through-year duration.

Qualifications

• 5+ years of Quality Engineering experience in the medical device industry.
• Strong understanding of Design Controls and how design requirements translate into manufacturing processes.
• Experience reviewing technical documentation and identifying quality or compliance gaps.
• Strong technical writing and document review skills.
• Ability to evaluate statistical analyses, process capability, and data trends.
• Experience supporting manufacturing quality and process improvements.

Responsibilities

• Review validation, characterization, and manufacturing documentation for technical accuracy, completeness, and regulatory compliance.
• Evaluate statistical analyses, process capability data, and technical reports to identify data abnormalities, unsupported conclusions, or documentation gaps.
• Review characterization reports to ensure equipment and manufacturing processes are adequately supported by data.
• Assess acceptance criteria and determine whether conclusions are technically justified and defensible.
• Support remediation efforts by identifying opportunities to strengthen manufacturing processes and quality documentation.
• Partner with cross-functional teams to resolve documentation gaps and improve technical justifications.
• Support equipment qualification activities as needed, including review of validation documentation and associated deliverables.

Skills

Quality Engineering

Medical devices

Design Controls

Technical writing

Statistical analysis

Documentation review

Tools

IQ/OQ/PQ knowledge

CPP reports understanding

FAT/SAT familiarity

Job description

Title: Quality Engineer (Medical Devices)

Location: Cincinnati, OH (Onsite preferred 5 days/week. Will consider exceptional candidates able to work 4 days/week onsite.)

Duration: Through the end of the year with potential for extension

Start: Early September

Position Summary

Our medical device client is seeking a Quality Engineer to support Manufacturing Quality Operations. While the role will have exposure to equipment qualification activities, this is not a traditional Validation Engineer position.

The primary need is for a Quality Engineer who can critically evaluate technical documentation, identify gaps, assess statistical analyses, and ensure manufacturing and validation documentation is technically sound and inspection ready. The ideal candidate enjoys reviewing complex technical reports, asking the right questions, and strengthening documentation.

Primary Responsibilities

• Review validation, characterization, and manufacturing documentation for technical accuracy, completeness, and regulatory compliance.
• Evaluate statistical analyses, process capability data, and technical reports to identify data abnormalities, unsupported conclusions, or documentation gaps.
• Review characterization reports to ensure equipment and manufacturing processes are adequately supported by data.
• Assess acceptance criteria and determine whether conclusions are technically justified and defensible.
• Support remediation efforts by identifying opportunities to strengthen manufacturing processes and quality documentation.
• Partner with cross-functional teams to resolve documentation gaps and improve technical justifications.
• Support equipment qualification activities as needed, including review of validation documentation and associated deliverables.

Types of Documentation Reviewed

The contractor may support the review of documentation including:

• Equipment validation documentation (IQ, OQ, PQ, PPQ, relocation qualifications)
• Characterization reports
• Capability studies
• Critical Process Parameter (CPP) reports
• User Requirements Specifications (URS)
• Factory and Site Acceptance Testing (FAT/SAT)
• Validation Plans and Reports
• PFMEAs
• Control Plans and Quality Plans
• CTQ reports
• Device Master Records (DMRs)
• Bills of Material
• Engineering drawings
• Operating procedures
• Build protocols and reports
• General technical studies and reports

Required Qualifications

• 5+ years of Quality Engineering experience in the medical device industry.
• Strong understanding of Design Controls and how design requirements translate into manufacturing processes.
• Experience reviewing technical documentation and identifying quality or compliance gaps.
• Strong technical writing and document review skills.
• Ability to evaluate statistical analyses, process capability, and data trends.
• Experience supporting manufacturing quality and process improvements.
• Excellent critical thinking skills with the confidence to ask challenging questions and defend technical conclusions.