Job Description
The Quality Manager role serves as the Person Responsible for Regulatory Compliance for the EU Authorized Representative under EU MDR 2017/745.
This position leads the sustainment, improvement, and globalization of the quality management system in support of medical devices and combination products.
-----------------------------------
Responsibilities:
* Serve as the PRRC for the EU Authorized Representative, fulfilling all in-country obligations under EU MDR 2017/745.
* Host external audits in the EU region, demonstrating quality management system compliance to external regulators for ISO 13485 and other country-specific device audits.
* Conduct internal audits to assess the compliance of the quality management system in accordance with ISO 13485 and other country-specific device regulations under MDSAP.
* Lead root cause investigation and corrective action planning in response to external and internal audit observations.
-----------------------------------
Required Skills and Qualifications
Qualifications: Bachelor's degree, preferably in engineering, physical science, life science or pharmacy. Minimum of 7 years of industry experience in a GXP regulated environment.
ISO 13485 Lead Auditor certification by a professional body is preferred.
-----------------------------------
Benefits
This is a hybrid role with 3 days on site, 2 days remote.
-----------------------------------
Others
Able to influence without direct authority and apply past learnings to novel situations.