Quality Engineer

Harba Solutions Inc. • Full-time • Fishers, IN, US • 1d ago

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

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