Quality Engineer
Job in
Fishers, Hamilton County, Indiana, 46085, USA
Listed on 2026-08-04
Listing for:
Harba Solutions Inc.
Full Time
position Listed on 2026-08-04
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, Production QC/QA, Quality Engineering
Job Description & How to Apply Below
- Lead or support validation activities, including process validation, equipment qualification, and inspection method validation
- Develop, review, and approve validation protocols and reports in compliance with regulatory and internal requirements
- Conduct hands‑on FMEA and PFMEA assessments, prioritizing failure modes and driving resulting corrective actions
- Own or investigate customer complaints from intake through root cause analysis and resolution
- Perform statistical process control, process capability analysis, and trend analysis to monitor and improve process performance
- Lead root cause investigations and implement corrective and preventive actions (CAPA)
- Manage batch record review and release, deviations, non‑conformities, and out‑of‑specification investigations
- Develop, maintain, and improve quality procedures, control plans, and technical documentation
- Collaborate cross‑functionally with operations, engineering, and other departments to ensure process reliability and product quality
- Support internal and external audits and regulatory inspections, acting as a subject matter expert as needed
- 3 or more years of experience in quality assurance, quality engineering, or process engineering within a manufacturing environment
- Bachelor's degree in a technical field such as engineering, materials science, data analytics, or statistics, or equivalent experience
- Direct, hands‑on experience with FMEA and PFMEA
- Demonstrated experience owning or investigating customer complaints
- Working knowledge of ISO 9001, ISO 13485, and applicable FDA cGMP requirements
- Strong analytical and problem‑solving skills, with experience in statistical tools such as SPC and process capability analysis
- Effective communicator able to adjust style across technical and non‑technical audiences
- Comfortable operating with ambiguity, shifting priorities, and a results‑oriented culture
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