Position Summary
Before applying for this role, please read the following information about this opportunity found below.
As part of its continued growth, a dynamic and global medical device organization are seeking a meticulous and organized Quality Specialist, Internal Auditor – QMS to join its team. They are dedicated to improving lives through advanced transplant technology.
The Internal Auditor – QMS is responsible for conducting internal audits across global sites to ensure compliance with company policies, quality standards, and applicable regulations. The ideal candidate will possess excellent attention to detail, strong organizational abilities, and a background in conducting thorough, value-added audits that support ongoing quality system improvements.
This role is vital for ensuring that company operations align with the Quality Management System (QMS).
Responsibilities:
* Conduct internal audits to ensure compliance with FDA 21 CFR Part 820, ISO 13485, EU MDR, and other applicable standards.
* Evaluate organizational processes against defined quality standards.
* Identify areas for improvement and propose corrective actions within the QMS.
* Perform risk assessments and analyze audit outcomes to detect trends or systemic issues.
* Prepare and present detailed audit reports to management.
* Support development and implementation of corrective action plans based on audit findings.
* Provide training and guidance to staff regarding quality standards and QMS principles.
* Monitor and verify the effectiveness of implemented corrective actions.
* Stay informed on the latest developments in relevant quality standards and regulations.
* Comply with the company’s Code of Conduct and all other corporate policies.
Requirements:
* University or college degree, preferably in a scientific or quality/regulatory discipline.
* Minimum of 3 years of experience in medical device quality auditing, or a comparable combination of education and experience
* In-depth knowledge of medical device regulations including FDA QSR, ISO 13485, ISO 14971, EU MDR, MDSAP, and CMDR.
* Strong analytical skills and a focus on process improvement.
* Ability to present findings clearly and respond professionally to stakeholders including management, customers, and suppliers.
* High emotional intelligence and professional demeanor to ensure positive engagement with auditees during audits.
* Proficiency in Microsoft Office tools (Excel, PowerPoint, Visio, Word, Access).
* Strong organizational and time-management skills.
* Experience in quality audits preferred; lead auditor certification in ISO 13485, MDR, or MDSAP is an asset.