Helio Genomics · 16 hours ago
Quality Systems Manager
West Lafayette, IN
Full-time
Onsite
Mid, Senior LevelHelio Genomics is an AI-driven healthcare company focused on early cancer detection and affordable testing. They are seeking a Quality Systems Manager to lead the development and improvement of the Company Quality Management System in compliance with relevant regulations and guidelines.
Health CareHealth DiagnosticsPersonal Health
Responsibilities
Utilize the company’s electronic Quality Management System (eQMS) to ensure full implementation of quality and manufacturing processes
Provide Quality System expertise and support to the broader organization
Develop and maintain organized records that demonstrate compliance with company processes, regulations, and the QMS
Serve as the primary point of contact for Laboratory Operations activities, including non-conformances (NCRs), supplier management, and corrective/preventive actions (CAPAs/SCARs)
Lead improvement projects initiated from non-conformances, audit findings, and customer complaints
Support routine Quality processes, including document control, employee training, and the tracking of quality metrics
Prepare and report QMS metrics for Management Review
Participate in internal and external audits, including preparation, management, and post-audit follow-up
Maintain a constant state of inspection readiness and represent the Quality department in cross-functional meetings
Comply with all personal protective equipment (PPE) requirements for the BSL-2 laboratory environment
Qualification
Required
Bachelor's degree in Engineering, Biology, or a related scientific discipline
Extensive knowledge of medical device/IVD regulations (FDA 21 CFR 820, ISO 13485, ISO 14971)
Proven track record in the medical device or biotechnology industry; Certified Quality Professional preferred
Demonstrated ability to perform internal audits and support external inspections
Strong project management skills with the ability to drive root cause identification and corrective actions
Excellent verbal and written communication skills, including proficiency in data compilation and technical writing
Strong interpersonal skills with the ability to work effectively within cross-functional teams
Exceptional time management and organizational skills; able to multi-task and meet deadlines in a fast-paced environment
Ability to work independently while remaining flexible to changing requirements
Ability to align department achievements with overall organizational success
Working knowledge of Microsoft Office applications and eQMS systems
Preferred
Experience using Arena (eQMS)
Experience with both IVD and CLIA quality regulations
Quality Certification(s)
Company
Helio Genomics
Helio Genomics is a healthcare company that focuses on the early detection of cancer.
Founded in 2014
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Bharat Tewarie
Chief Executive Officer
Gary D. Frazier
Chief Growth Officer
Recent News
2025-12-16
Company data provided by crunchbase