Senior Software Quality Engineer - Carlsbad, United States - Gilero

Description

Job Purpose:

Responsible for directing, managing, and maintaining the development, validation and control of

software products such as embedded software, applications, and software as a medical device

(SAMD).

Duties:

• Lead software verification and validation activities for products under development in accordance with company procedures.
• Author and approve software test case protocols and reports, software development plans, and other system/software documentation.
• Lead software development projects from product classification, software requirements, development, verification and validation through regulatory clearance.
• Lead medical device software development and test teams internally and externally.
• Provide Quality oversight of software plans, software development, verification, maintenance, and storage.
• Perform risk evaluation and associated management activities related to software development including FMEA, product risk analysis and mitigation, software safety classification, and level of concern.
• Prepare documentation for regulatory filings.
• Provide mentorship and guidance to engineers involved in software quality activities.
• Support Gileros growth through scaling internal and external software quality resources.
• Identify and implement improvements to the Quality Management System, software development lifecycle and testing practices within the company.
• Participate as team member on new product development projects as quality function representative. Provide support for product and process development activities.
• Maintain a strong, collaborative partnership with cross functional team members.
• Lead internal corrective and preventative actions (CAPA) process and perform effectiveness checks as appropriate, as needed.
• Perform process validations (IQ/OQ), as applicable, including test or other equipment utilizing software, user controls and data management, as needed.
• Support internal and external audits, as needed.
• Support non-product software validation by assessing the need for validation and preparing test scripts and executing protocols, writing reports and other documentation, as required.
• Support company compliance to 21CFR Part 11 compliance and data integrity policies.

Skills/Qualifications:

Minimum:

• Bachelor's degree in engineering, science, or relevant field
• 5-10 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
• Expert with IEC , IEC 62304, and FDA software development guidelines.
• Expert 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
• Prior experience managing software test programs to include unit, integration, and system testing

Preferred:

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

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.