Senior Software Quality Engineer

Role responsibilities

The role involves maintaining and improving the company's Quality Management System to ensure compliance with medical device regulations. The engineer will perform assessments of client QMS documents and Design History Files while providing recommendations for remediation.

Requirements

Candidates must have a bachelor's degree in a relevant technical field and at least 8 years of experience in software quality engineering within the medical device industry. Proficiency in FDA QSR, ISO 13485, IEC 62304, and ISO 14971 is required.

Key skills

Quality Management Systems, FDA QSR, ISO 13485, IEC 62304, ISO 14971, Software Development Life Cycle, Design History Files, Internal Auditing, CAPA Management, Regulatory Compliance, Software Engineering Best Practices, Technical Writing, Quality Assurance, Risk Management, Project Leadership, Communication Skills

Keywords

Medical Device, QMS, FDA, ISO 13485, ISO 14971, IEC 62304, SDLC, Design History File, DHF, ASQ, RAC, CAPA, Quality Assurance, Regulatory Affairs, Software Quality Engineering, Audit, Design Control, Bioinformatics, Software Engineering, Compliance