Urgo Medical North America · 22 hours ago
Senior Quality Assurance Specialist
Fort Worth,TX,US
Full-time
Onsite
Senior Level
5+ years expUrgo Medical North America is seeking a Senior Quality Assurance Specialist responsible for executing various tasks for Quality Assurance and Manufacturing Operations processes. The role focuses on supporting CAPA processing, complaint investigations, and ensuring compliance with FDA regulations while providing QMS support across functional organizations within the company.
Medical Device
Responsibilities
Ensure the thorough and accurate processing of CAPAs, including root cause analysis (RCA), solution development, and effectiveness verification for internal and external CAPAs
Assist CMOs with technical investigations and monitor for timely responses related to CAPAs and complaints
Collaborate with Customer Success in the handling of complaints, initiate reporting of Medical Device Reporting/Adverse Events (refer to 21 CFR 820.198 and 21 CFR 803), and oversee complaint investigation execution
Collaborate with Medical Affairs as needed to obtain guidance and expert subject matter on complaints related to adverse reactions, and for final resolution determination
Develop and distribute periodic CAPA and complaint status reporting
Ensure QMS documented information and records control processes meet GDP compliance
Support QMS processes such as document change requests, change control requests, nonconformities, and audit activities
Support the periodic review of QMS documents according to ISO requirements
Contribute toward the implementation and improvements of eQMS applications and tools
Assist with and support QMS training cross-functionally and within the team, as needed
Support and participate in internal and external audits, regulatory inspections, and supplier audits, as needed
Other duties as assigned
Qualification
Required
Bachelor's degree is required
Experience with CAPA processing and complaint investigations
Competent in understanding of the regulatory landscape in the US, Canada, as well as MDR requirements
Knowledgeable in ISO 13485:2016 Standard requirements
Minimum 5 years of relevant document control management experience in a cGMP/FDA regulated environment
Proficient in Microsoft Suite and other organizationally leveraged applications (e.g., Word, Adobe, Visio Excel, and SharePoint) and with QA Systems (e.g., Document Management System, Quality Management System)
Preferred
Experience in Project Management or Document Management preferred
Company
Urgo Medical North America
Urgo Medical North America, formerly known as SteadMed Medical, provides medical devices and products to hospitals, nursing homes and home health agencies – and the patients they treat – with a focus on acute, chronic, and surgical wounds, and additionally skin moisturization.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase