Proclinical Staffing · 11 hours ago
Quality Systems Manager
Indiana, United States
Full-time
Hybrid
Mid, Senior Level
3+ years expProclinical Staffing is seeking a Quality Systems Manager for an exciting AI-driven medical diagnostics company based in Indiana. The role involves leading the development and improvement activities associated with the Company Quality Management System in accordance with relevant FDA and ISO regulations.
Staffing & Recruiting
Hiring Manager
Phu Huynh
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
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
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). Minimum 3 years of QA industry experience
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
Preferred
Certified Quality Professional
Experience with both IVD and CLIA quality regulations
Company
Proclinical Staffing
At Proclinical Staffing, our life science recruitment services support our partners with permanent and contract vacancies by connecting them with specialist talent across the globe.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase