Position at a glance
| Item | Details |
|---|---|
| Position | Quality Systems Manager, Medical Device and IVD |
| Function | Quality and Compliance |
| Level | Manager |
| Employment type | Full-time |
| Employer | Hopkins MedTech Group LLC, doing business as Hopkins MedTech Compliance |
About the role
The Quality Systems Manager owns the quality management system that HMC's clinical and regulatory work runs on, and leads quality system projects for medical device and in vitro diagnostic (IVD) clients. The role keeps procedures, records and training in a state that stands up to a sponsor audit or a regulatory inspection.
You will work across clinical operations, regulatory affairs and data teams, and directly with client quality leaders who are building or remediating their own systems.
Responsibilities
- Maintain and improve HMC's quality management system: document control, training, deviation handling, corrective and preventive action (CAPA), change control, supplier qualification and management review.
- Lead client projects to build or remediate quality systems against ISO 13485:2016 and the FDA Quality Management System Regulation (21 CFR Part 820).
- Plan and run internal audits, host sponsor and client audits, and support clients preparing for FDA inspections and notified body audits.
- Own the electronic quality management system and other regulated systems, including computer system validation and 21 CFR Part 11 controls for electronic records and signatures.
- Qualify and monitor vendors and laboratory partners used in client studies.
- Apply risk management under ISO 14971 to procedures, studies and client quality system work.
- Review study and submission records for compliance with Good Clinical Practice and Good Documentation Practice before release.
- Report quality metrics and trends to leadership, and follow corrective actions through to verified closure.
Qualifications
- Bachelor's degree in a life science, engineering or a related field.
- At least 6 years of quality assurance or quality systems experience in medical devices, in vitro diagnostics or a CRO, including ownership of core quality system processes.
- Working knowledge of ISO 13485, 21 CFR Part 820, 21 CFR Part 11 and ICH E6 Good Clinical Practice.
- Experience leading audits and managing CAPA from investigation to effectiveness check.
- The ability to write procedures that people can follow, and to explain a finding without overstating it.
Preferred experience
- ISO 13485 lead auditor qualification or ASQ certification (CQA or CQE).
- Experience implementing or administering an electronic quality management system.
- Experience with IVDR or MDR quality system requirements and the Medical Device Single Audit Program (MDSAP).
- Experience supporting clients through an FDA inspection.
About Hopkins MedTech Compliance
Hopkins MedTech Compliance is an independent contract research organization (CRO) for medical devices and in vitro diagnostics (IVD). Operated by Hopkins MedTech Group LLC, a New Jersey limited liability company, we plan and run clinical performance studies and prepare the regulatory submissions that follow, for the United States (FDA) and the European Union.
How to apply
Send your CV and a short note naming this role (HMC-FT-02) to info@hopkinsmedtech.com, or use the contact page.
