Division/Department: InstruSafe
Type of Position: Full-Time
Summit Medical, an Innovia Medical Company
March 2026
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Innovia Medical combines the experience and expertise of Summit Medical, Network Medical, DTR, Eagle Labs, Grace Medical and Hurricane Medical to help our medical professional partners elevate the delivery of care to improve patient outcomes. We develop products not just for our customers, but with our customers. Our collaborative approach cultivates innovative medical solutions for the global healthcare industry. Through excellence in design, supply chain management, manufacturing and customer service we put quality at the forefront in all aspects of our business.
Job Summary
We are seeking a detail-oriented Quality Assurance Specialist to support compliance and quality management activities within the InstruSafe® division of Summit Medical/Innovia Medical. The role ensures adherence to international regulations and standards and maintains the company’s Quality Management System (QMS). This position requires strong knowledge of medical device regulations (e.g., FDA, EU MDR, ISO 13485) and excellent cross-functional collaboration.
Essential Duties and Responsibilities
Quality Management System (QMS)
- Maintain and improve the QMS in compliance with ISO 13485, 21 CFR Part 820, and applicable standards.
- Support internal and external audits, inspections, and corrective actions.
- Ensure document control, training, and change management processes are properly implemented.
Product Lifecycle Support
- Partner with R&D, manufacturing, and clinical teams to ensure design control, risk management, and post-market surveillance compliance.
- Review and approve quality aspects of labelling, promotional materials, and product changes.
- Support vigilance reporting, complaint handling, and CAPA activities.
Cross-Functional Collaboration
- Provide regulatory and quality guidance during new product development.
- Liaise with regulatory authorities, notified bodies, and certification agencies.
- Train employees on quality compliance topics.
- Perform other duties as assigned by manager or supervisor
Experience & Education Requirements
- Bachelor’s degree in engineering, life sciences, regulatory affairs, or related field or equivalent work experience in those areas.
- 2-4 years of experience in quality affairs in the medical device industry.
- Strong knowledge of ISO 13485, ISO 14971, 21 CFR Part 11/820, EU MDR 2017/745.
- Excellent analytical, organizational, and communication skills.
Preferred Skills & Abilities
- Medical device industry experience
- Medical Device regulation requirements knowledge, as applicable to responsibilities
- Quality Assurance Certification (e.g., CQE, CQA) is a plus.
We offer a full complement of benefits including health, dental, vision, life insurance, LTD/STD, 401(k) and generous PTO. Come work for a growing company that offers a fun, collaborative environment with work-family balance.
**This position is primarily on-site at our corporate headquarters in Eagan, MN (near 494/Dodd). After initial training period, you will be given the option to work one day a week from home**
Qualified applicants should submit their resume to careers@innoviamedical.com
Applicants for employment must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States (i.e., H1-B visa, F-1 visa (OPT), TN visa or any other non-immigrant status).
EOE/Disabled/Veteran
