A Quality Systems Engineer is required to develop and maintain a compliant Quality Management System (QMS).
Reporting to the QA/RA Manager, this role will lead hands-on in developing procedures and systems for full compliance with US FDA QSMR regulations.
The Role:
Plan and execute the development of the Company QMS from initial Gap Analysis to Final Compliance,
writing new and revising existing procedures and systems as needed.
* Provide monthly project progress reports to management.
* Participate in third-party QMS audits and support continuous improvement initiatives.
* Develop and implement sound, systematic problem-solving methodologies to identify and resolve quality issues.
Key Requirements:
Bachelor's Degree in Engineering, Science, Quality Management, or a related field.
At least 4 years of industry experience in Medical Device Manufacturing within US FDA compliant companies.
Skills: Quality Systems Engineer ISO13485 US FDA QSMR