Quality Systems Specialist

Quality Systems Specialist Retham Technologies Wauwatosa, WI Job Details Part-time | Full-time 1 day ago Benefits Health insurance Dental insurance Paid time off Qualifications ISO certification process Bachelor's degree Biomedical regulatory compliance Productivity software Quality systems FDA regulations Full Job Description 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 (20-40hrs/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 Supports supplier qualification 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 Support Management Review Comply with legal and regulatory requirements applicable to the 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 ASQ certification Knowledge of FDA regulations related to medical device manufacturing (QMSR)

WORK LOCATION

in-office (potential hybrid) Retham Technologies is an Equal Opportunity Employer and makes employment decisions without regard to race, color, religion, sex, national origin, veteran status, disability, or any other protected class. Applicants must be authorized to work in the United States without the need for visa sponsorship now or in the future.

Benefits:

Dental insurance Health insurance Paid time off

Education:

Bachelor's (Required)

Experience:

Quality systems: 2 years (Preferred)

Work Location:

In person