Quality Systems Specialist Job Madison area,Wisconsin USA,Quality Assurance

Retham Technologies, Inc. is a clinical diagnostic start-up company developing an IVD assay for a blood clotting disorder, heparin-induced thrombocytopenia. The company is conducting clinical trials of the IVD with plans to file for regulatory clearance followed by market launch.

Job Title: Quality Systems Specialist

Status: Full-Time or Part-Time role (20-40 hrs/week)

Job Summary: The Quality System Specialist leads the development, maintenance, and continuous improvement of the company’s Quality Management System (QMS) in compliance with ISO 13485 and FDA QMSR standards. This role ensures that all quality processes, records, and documentation meet applicable regulatory and customer requirements. The Specialist will collaborate with cross‑functional teams to promote a strong quality culture, maintain compliance, and drive system effectiveness.

ESSENTIAL

DUTIES

Implement, maintain, and continuously improve the Quality Management System to comply with ISO 13485 and FDA QMSR standards
Provide training to employees on ISO and regulatory requirements, documentation procedures, and quality system changes
Administer the document control process, including approvals, revisions, and obsolescence
Ensure controlled distribution, revision, and accessibility of procedures, forms, and work instructions
Plan, schedule, and conduct internal quality audits
Lead preparation for customer and supplier audits, external certification, regulatory and surveillance audits
Track and verify completion of QMS corrective actions from audits, nonconformances, or management reviews
Facilitate and document Corrective and Preventive Actions (CAPA) for QMS findings
Ensure root cause analysis and effective verification of implemented solutions
Support risk management activities related to quality system compliance
Comply with legal and regulatory requirements applicable to our business

MANDATORY QUALIFICATIONS

Bachelor’s degree in Quality, Engineering, or a relevant scientific discipline
Working knowledge of ISO 13485 requirements
Experience working in a Quality Management setting for FDA regulated products
Proficient using Microsoft Office and standard office software solutions

PREFERRED QUALIFICATIONS

Experience with electronic QMS systems
Knowledge of FDA regulations related to medical device manufacturing (QMSR).

WORK LOCATION: In office with flexibility

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