Job Summary
The Quality Systems Specialist III will play a pivotal role in maintaining and enhancing our QMS to ensure compliance with ISO 13485, FDA, EU MDR regulations, and other applicable international standards. This position will be responsible for measuring effectiveness and leading the continuous improvement of the QMS, ensuring effective corrective and preventive actions (CAPAs), and helping lead internal and external audits and regulatory inspections. The ideal candidate will have a strong background in medical device quality systems and regulatory requirements, with a proven ability to collaborate cross-functionally and present to leadership to ensure the highest level of quality assurance across the organization.
Responsibilities
QMS Management & Improvement
Regulatory Compliance & Audits
Documentation & Reporting
CAPA & Non-Conformance Management
Cross-functional Collaboration and Support
Knowledge, Skills, and Abilities
Knowledge/Skills
Personal Attributes
Qualifications
Education
Experience
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