Quality Engineer: Validation & CAPA Lead

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

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.