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2 months ago

Jamesburg, United States BioTalent Full time

Introduction We are working with a cardiovascular device manufacturer seeking a

Senior Quality Assurance Manager

to join their team out of the Dallas/Fort Worth area. You will be responsible for reviews and approves critical documents such as Device History Records, SOPs, Validation Protocols, Deviation Reports, and CAPA Reports to ensure operational support and compliance. This role will offer you Direct leadership capabilities overseeing a team of 20 individuals. Report into the VP of QA/RA for high-visibility and growth opportunities. Annual Bonus + 401(k). You will be responsible for Reviews and approves documents, including Device History Records, Standard Operating Procedures, Validation Protocols and Reports, Deviations, Engineering Change Requests, and Non-Conforming Materials Reports, CAPA Reports, Complaint investigations and Supplier Corrective Action Reports to ensure operational support and compliance. Leads root cause and failure analysis investigations to ensure effective CAPA resolution. Solve problems using Cause & Effect diagrams, FMEA, Root Cause Analysis, etc. Perform Corrective Actions and Non-conformance assessments. Utilize project management strategy at a department level to successfully execute multiple projects with competing resources and prioritization. Manages and develops the Quality Operations and Quality Engineering leadership staff. You will bring the following BS in an engineering capacity

is required. 5 years in a managerial capacity

is required. Experience in regulated, relevant environments (FDA 21 CFR Part 820, ISO 13485, ISO 14971, etc.). Certified ASQ is preferred. Certified auditor is preferred.

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