Quality Engineer
Job in
Grover Hill, Paulding County, Ohio, 45849, USA
Listed on 2026-09-14
Listing for:
Intellectt INC
Full Time
position Listed on 2026-09-14
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist -
Engineering
Quality Engineering, Process Engineer, Regulatory Compliance Specialist
Job Description & How to Apply Below
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.
- 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
- 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
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