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Quality Assurance Manager

2 months ago


Houston, United States Brainco Full time

The Quality Assurance Manager is responsible for developing, implementing, and managing quality control systems designed to ensure continuous production/service consistent with established standards, customer specifications, and production goals. The role involves working with various departments to maintain and improve product quality and ensure compliance with industry standards and regulations.The daily work will require both QA and QC functions to be executed by the individual.

Key Responsibilities: Develop, implement and maintain Quality system documentation. Update and maintain OP’s and SOP’s in conjunction with department heads Manage CAPA Reports and Root cause analysis. Monitor CAPA actions, follow ups and reporting Test products and services including a variety of tasks involved from Incoming, MRB to final release and DHR Review. Manage documentation and reporting including A variety of tasks from ECO/ECN/DCO operations and approvals, as well as monthly, quarterly and annual reports (CAPA, Supplier, NCR ect) Assist and perform internal and supplier management and audits Establish Administer Calibration Program and maintain regularly

Qualifications: Bachelor's degree in Quality Assurance, Engineering, or a related field. 5+ years of experience in quality system operation Relevant work experience in Med tech Class 1 or Class 2 is required, with a focus on hardware and ISO 14385 A quick decision maker with great teamwork skills and detail-oriented personnel Hands-on experience with hardware, hardware engineering, parts, drawings. Prior exposure to customary inventory processes is required. Able to use standard office environment software and demonstrated proficiency in XLS. Ability to prioritize and respond to changing needs and demands. Excellent analytical and presentation skills is preferred

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