Quality Engineer

Hiring: Quality Engineer
Location: Ohio (OH)
Pay Rate: $44 $50/hr on W2
We are looking for a Quality Engineer to support Manufacturing Quality Operations within a medical device environment. The ideal candidate will have strong experience reviewing technical and validation documentation, evaluating statistical data and process capability, identifying gaps, and ensuring manufacturing and quality documentation is technically sound and inspection-ready.

Key Responsibilities:
Review validation, characterization, and manufacturing documentation for accuracy and compliance
Evaluate statistical analyses, process capability data, and technical reports
Identify data abnormalities, documentation gaps, and unsupported conclusions
Review equipment and process characterization reports
Evaluate acceptance criteria and technical conclusions
Support manufacturing quality and process improvement activities
Partner with cross-functional teams to resolve documentation and quality gaps
Support equipment qualification and validation activities as needed

Requirements:
Strong knowledge of Design Controls and manufacturing processes
Experience reviewing technical and quality documentation
Strong technical writing and document review skills
Experience with statistical analysis, process capability, and data trends
Knowledge of IQ/OQ/PQ, PPQ, equipment qualification, and validation documentation
Experience with PFMEA, Control Plans, CTQ, CPP, URS, FAT/SAT, and technical reports
Strong critical thinking, problem-solving, and communication skills
Ability to challenge technical conclusions and identify quality/compliance gaps
Managerial references required