Head of Quality Systems/Senior Quality Systems Specialist

Retham Technologies, Inc.

Wauwatosa, WI 53226

Join an innovative clinical diagnostics startup bringing a breakthrough diagnostic to hospital laboratories.

Retham Technologies is developing a first-of-its-kind in vitro diagnostic (IVD) assay for heparin-induced thrombocytopenia (HIT), a life-threatening blood clotting disorder. Backed by more than $6 million in NIH funding, our team is preparing for FDA submission and commercialization. We are seeking an experienced Senior Quality Systems Specialist to help build a world-class Quality Management System while working directly with company leadership in a collaborative startup environment.

Position

· Senior Quality Systems Specialist

· Full-Time (will consider part-time role)

· Location: Wauwatosa, WI (on-site preferred, open to hybrid)

Basic Requirements

· Authorized to work in the United States without current or future visa sponsorship

· Able to work primarily on-site in Wauwatosa, WI (open to hybrid)

· Prior quality experience in an FDA-regulated medical device, IVD, biotechnology, or life sciences company

Position Summary

Lead implementation, maintenance, and continuous improvement of Retham's Quality Management System in compliance with ISO 13485 and FDA QMSR. Partner closely with leadership, R&D, operations, and regulatory to support FDA clearance and commercialization.

Key Responsibilities

· Implement and continuously improve the ISO 13485-compliant electronic QMS

· Administer document control

· Plan and conduct internal quality audits

· Prepare for customer, supplier, certification, and FDA audits

· Lead CAPA activities and root cause investigations

· Support supplier qualification and quality agreements

· Support risk management and management review

· Train employees on quality system requirements

Success in Your First Year

· Complete implementation of the company's core QMS

· Support FDA submission activities

· Strengthen supplier quality processes

· Foster a strong quality culture across the organization

Required Qualifications

· Bachelor's degree in Quality, Engineering, Biology, Chemistry, or related scientific discipline

· 3+ years of Quality Systems experience in an FDA-regulated medical device or IVD company

· Working knowledge of ISO 13485 and FDA QMSR/QSR

· Experience with document control, CAPA, internal audits, supplier quality, and/or risk management

· Strong technical writing and Microsoft Office skills

Preferred Qualifications

· Experience in an IVD or diagnostics company

· Experience supporting FDA 510(k) submissions

· Experience with electronic QMS software

· ASQ CQA certification

· Startup or small-company experience

Why Join Retham

· Direct interaction with executive leadership

· Opportunity to build a quality system from the ground up

· Meaningful ownership and visibility

· Equity participation opportunity

· Flexible work schedule

· Competitive salary

Equal Opportunity

Retham Technologies is an Equal Opportunity Employer. Qualified applicants will receive consideration without regard to any protected status. Applicants must be authorized to work in the United States without the need for visa sponsorship now or in the future.