Quality Assurance Engineer

July 22

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Altoida, Inc.

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Creating a New Gold Standard in Brain Health With Precision Neurology.

Mobile Health • Digital Health • Medical Device • Healthcare • Predictive Health

11 - 50

💰 $14M Series A on 2022-03

Description

• Implement, maintain and continuously improve Quality Management System processes. • Maximize the quality of the processes and the products these produce, while driving corrective action and continuous improvement efforts. • Work with cross functional teams and Customers to achieve quality and regulatory compliance goals in projects and during the software development lifecycle. • Coach project teams and process owners, distributing quality metrics throughout the software lifecycle contributing to business and technical risk management, as well as preparing for external audits and inspections from customers and regulatory authorities, if required • Improve and maintain processes for Document Control, CAPA, Nonconforming Material, Training and Complaints. • Lead the organization in the development and use of the Risk Management Plan, FMEA and overall process development and execution. • Implement, maintain and continuously improve the process by which to create and control Design Control documentation, such as DHFs and DMRs. • Lead and manage the Internal Audit and Supplier Management processes

Requirements

• Minimum of 5 years of directly related work experience in Quality Assurance within the medical device, medical device software and/or biotechnology industries. • Software quality experience is a plus. • Working knowledge of the FDA’s QSR, ISO 13485, ISO 14971, IEC 62304 and other applicable software standards. • Proven experience in quality management of software products preferred. Understand the software development and software product lifecycle phases • Bachelor’s Degree preferably in a Science or an Engineering or related technical discipline. • ASQ Certifications or equivalent a plus - CQA, CQE, CMQ/OE, CSQE