Software Quality Engineer - Medical Devices

Job Purpose :

Responsible for quality oversight of the design, development, and production of medical device and combination products with a focus on software interface requirements, embedded systems and Data Integrity across the organization in alignment with the quality system.

Duties :

• Lead software verification and validation activities for development products including review and approval of software test case protocols and reports, software development plans, and other system and software documentation required to establish software requirements.
• Author / review software and design history file required documents from a Quality oversight perspective.
• Perform risk evaluation and associated activities related to software development including FMEA, product risk analysis, and mitigation.
• Prepare documentation for IEC 60601-1 and IEC 62304 compliance
• Lead non-product software validation assessing the need for validation and preparing test scripts, executing protocols, and writing reports.
• Identify and implement improvements to the Quality Management System, validation master planning, software development lifecycle and testing practices within the company.

Develop policies for management and assessment of non-product software releases.

• Oversee company compliance to 21CFR Part 11 compliance and data integrity policies. Act as company Data Integrity Officer.
• Execute quality event initiation, investigation, and closure for nonconformance's, CAPA, change control and complaints.

Perform effectiveness checks.

• Perform equipment process validations (IQ / OQ), as applicable, including test or other equipment utilizing software, user controls and data management.
• Support internal and external audits.

Skills / Qualifications :

Minimum :

• Bachelor's degree in engineering, science, or relevant field
• 0-5 years in regulated manufacturing and / or development environment
• Proficiency with FDA 820 CFRs / ISO 13485 / cGMP quality management system and requirements for medical devices and combination product development and manufacturing
• Experience with IEC 60601-1, IEC 62304, and FDA software development guidelines.
• Experience using risk analysis and continuous improvement concepts
• Extensive experience with GxP requirements
• Strong technical written and verbal communication skills
• Experience leading and / or supporting audits

Preferred :

• Master's or advanced degree in relevant field
• 5+ years in pharma or medical device manufacturing and / or development environment
• Excellent interpersonal, change management, planning and organizational skills
• Software lifecycle management experience in phase appropriate environments ranging from pre-clinical to commercial
• Project management experience
• CQE ASQ or related certification

Personal Attributes :

• Meets Gilero Core Values : Collaboration, Innovation, Excellence, Integrity
• Productive in a fast-paced, entrepreneurial environment.
• Commits to excellence and quality service to external and internal customers.
• Adheres to established policies and procedures, while contributing to continuous improvements
30+ days ago