Overview
Quality Assurance Specialist Jobs in Greater Indianapolis at Harba Solutions Inc.
Title: Quality Assurance Specialist
Company: Harba Solutions Inc.
Location: Greater Indianapolis
Responsibilities
Maintain the Quality Management System (QMS), ensuring compliance with cGMPs, ISO 13485, and FDA regulations.
Review batch records, oversee final batch release, and issue Certificates of Conformity.
Manage deviations, change controls, and CAPAs, ensuring thorough root cause analysis and risk assessments.
Partner with Operations and Engineering to ensure compliance in processes, equipment, and systems.
Conduct internal audits, support regulatory inspections, and assist with audit responses.
Provide training on QMS processes, cGMPs, and quality standards to internal teams.
Identify and implement process improvements to enhance compliance and efficiency.
Facilitate the annual management review process.
Qualifications
Bachelor’s degree in Engineering, Material Science, or a related technical field (or equivalent experience).
2+ years of experience in Quality Assurance, Quality Engineering, or Process Engineering within manufacturing.
Strong knowledge of ISO 13485, FDA cGMPs, and quality system processes in medical device manufacturing.
Experience with risk management, CAPA processes, and regulatory audits.
Excellent problem-solving, project management, and technical writing skills.
Strong communication skills, with the ability to train teams on complex quality topics.
Proficiency in relevant IT tools (ERP systems, Microsoft Office, and QMS software).
Auditor certification (ASQ CQE, CQA, or CQM) is a plus.
