Overview
Quality Engineer Jobs in Fishers, IN at Harba Solutions Inc.
Title: Quality Engineer
Company: Harba Solutions Inc.
Location: Fishers, IN
Job Responsibilities:
- 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
Qualifications:
- 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
