Quality Engineer
Boston
Engineering /
Full Time /
Remote
Position Overview
The Quality Assurance Engineer (QAE) will lead the implementation, continuous improvement and maintenance of the Quality Management System for a Software as a Medical Device product to meet the requirements of the FDA's Quality System Regulation, ISO 13485 and other software standards and Regulatory requirements as required. Partner with Product Development and other functional areas during the product development lifecycle to bring a product to market and continue to provide support once product is commercially available.
Essential Job Functions
- 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
Other Skills/Abilities
- Microsoft Windows and/or Apple Operating Systems
- Microsoft Office tools – Word, Excel, PowerPoint
- Confluence, Jira
- Greenlight Guru
- Software Quality Assurance experience in Medical Device testing a plus.
- Quality Engineering experience in a Software only Medical Device a plus.
$60,000 - $75,000 a year
