Sr. Quality Systems/CAPA Engineer

The Opportunity

The Senior Quality Systems Engineer assures products conform to quality standards and establishes compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success. The position employs an individual skilled in advance quality assurance techniques with an in-depth understanding of the ISO 13485 Quality Standard and US 21 CFR 820 QSR. Areas of focus will include improving quality system infrastructure, performance metrics and ISO, FDA and GMP compliance.What You’ll Work On

Assure compliance with corporate and divisional requirements regarding metrics reporting for the Management Controls / Management Review and CAPA quality systems. 

Assure the collection, compiling, reporting and dissemination of key quality and compliance metrics/data are completed within the requiring timing.

Complete trend analysis of data as approp...

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