64 applicantsPosted by Agency
BioTalent ยท 2 days ago
Senior Quality Assurance Manager
DFW Metroplex
Full-time
Onsite
Senior Level
5+ years exp
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Hiring Manager
Cameron Cyker
Insider Connection @BioTalent
Responsibilities
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.
Qualification
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Required
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).
Preferred
Certified ASQ is preferred.
Certified auditor is preferred.
Benefits
Annual Bonus
401(k)
Company
BioTalent
BioTalent is life sciences recruitment agency with international reach and unrivalled knowledge & expertise.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase
