Quality Engineer

Harba Solutions Inc.; Fishers (IN); On-site; USD 70,000 - 110,000; Full time

Job summary

Harba Solutions Inc. in Indiana is seeking a Quality Assurance/Quality Engineering professional to lead process validation, batch record reviews, and CAPA initiatives.

You will drive PFMEA/FMEA activities, investigations of customer complaints, and improvements to quality systems in a manufacturing setting. The role requires hands-on experience with ISO 9001/13485 and FDA cGMP, strong analytical skills, and the ability to communicate across technical and non-technical teams.

Qualifications

• 3+ 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

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 corrective actions
• Own or investigate customer complaints from intake through root cause analysis and resolution
• Perform SPC, 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

Skills

FMEA/PFMEA

SPC analysis

CAPA leadership

Root cause analysis

Analytical problem solving

Communication skills

Education

Bachelor's degree in engineering, materials science, data analytics, or statistics

Job description

• 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