- Maintain and continuously improve Gentueri's Quality Management System in compliance with ISO 13485:2016 and FDA QMSR (21 CFR Part 820), and report its status and effectiveness to top management during management reviews.
- Own document control and change orders — review, approve, and maintain all electronic and paper quality documents and records, including a reliable backup system.
- Run the CAPA process and drive corrective and preventive improvements across processes and products.
- Manage customer complaints, including review for adverse events, and coordinate any device corrections, removals, or recalls.
- Review and disposition product nonconformances; review production records and approve final product release.
- Lead risk management activities and maintain Device Master Records, Device History Files, and the Design History File.
- Qualify and maintain approved supplier files.
- Plan, coordinate, and host internal and external audits as the Management Representative.
- Promote awareness of regulatory and quality requirements — and customer requirements — across the organization.
- Organize and lead management review meetings, and ensure adequate resources to maintain the quality system.
- Perform environmental monitoring of controlled areas (e.g., cleanrooms), including sampling, trending, and response to excursions.
- Conduct product quality control (QC) testing and inspection, and disposition results against specifications prior to release.
What We're Looking For
- 5+ years in the medical device industry, including hands-on experience with Class II or higher, sterile, and single-use and reusable devices.
- Strong working knowledge of ISO 13485 and FDA QSR/QMSR (21 CFR Part 820); familiarity with ISO 14971 (risk), ISO 10993 (biocompatibility), and ISO 11607 (sterile packaging).
- ISO 13485 Lead Auditor certification (or equivalent audit credential) preferred.
- A four-year degree in engineering, a life science, or a related technical field.
- The initiative to build a quality system from the ground up and the communication skills to embed quality across a small, fast-moving team without slowing it down.
We offer:
- Health, dental, and vision insurance available
- 3 weeks of PTO per year
- Remote work days
- A great team culture
- 30-40 hours/week
Company Description
Gentueri is a Wisconsin-based medical device company that designs and manufactures non-invasive biological sample collection and preservation devices and kits. Founded in 2012, the company takes its name from the Latin "tueri," meaning to protect — reflecting its mission to safeguard genetic material from collection through laboratory analysis. Gentueri works with genetic testing and forensic laboratories to improve the quality of results and laboratory efficiency, with products engineered for clean, well-preserved samples and easy automated processing