Sr. Software QA Engineer

Sr. Software QA Engineer

Vacancy expired!

Talent Space Inc is looking for a Senior Software QA Engineer in the bay area. It is a 50% remote role for now.

Position Summary
The Senior Software QA Engineer will be responsible for quality assurance activities related to software/system development, verification, validation, and overall system functionality and reliability of the CellFX System and accessories in support of our client's research and development, manufacturing, regulatory, clinical investigations, and commercial efforts. In addition, s/he will support the development and implementation of quality systems and regulatory filing activities.

Essential Duties and Responsibilities

• Provide expertise and guidance to product development and manufacturing teams in the areas of SW quality assurance, design controls and compliance.
• Develop, establish and maintain SW quality engineering methodologies, systems and practices that meet the Company's customer and regulatory requirements.
• Proactively investigate, identify and implement best-in-class SW quality engineering practices.
• Identify and implement effective process control systems to support the development, qualification and on-going manufacturing of products to meet or exceed internal and external requirements.
• Develop and validate SW methods, monitor medical device SW standards, facilitate and perform SW code review.
• Assist with preparation of regulatory submissions, regulatory assessments related to software changes and cybersecurity.
• Development of SW standard operating procedures, SW test methodologies, SW/product trace matrices, and software verification & validation protocols and reports.
• Design and implement methods and procedures for SW release, SW field upgrade, and final quality assurance.
• Work closely with the Software Development Team to plan, schedule, and improve development test processes.
• Work well in a collaborative team environment with other engineers, developers and end users with minimal supervision and ensure understanding and validation of business requirements.
• Perform validation and verification testing of medical devices and equipment in an FDA regulated environment.
• Support internal quality audits, management review activities, Notified Body audits (ISO), FDA QSIT audits, and QMS audits by country representatives.
• Carry out responsibilities in accordance with the organization's policies and applicable laws.
• Support the Company's Quality Policy and Quality System.

• BS degree in computer science, software engineering, or computer engineering.
• 7+ years of hands-on and progressive working experience in the field of SW quality assurance, SW testing, and/or SW development with at least 4+ years working with complex energy-based medical device system (such as Laser, RF, Ultrasound, Microwave, etc.).
• Experience with various FDA software validation and Cybersecurity guidance's and IEC 62304 Software Lifecycle process standard requirements are required.
• Must also have working knowledge and experience in the following areas: Design Control, Design & Process Validation, Risk Management, Cybersecurity, Quality system compliance, Complaint handling, MDR/Vigilance Reporting, and CAPA program.
• Familiarity with the use of quality disciplines, tools, and methodologies.
• Experience with the following applicable standards and software packages:
  • ANSI/AAMI/IEC 62304:2006 Medical device software -Software life cycle processes.
  • Medical Electrical Safety and EMC standards (IEC 60601-1, IEC 60601-1-2).
  • Risk Assessment (ISO 14971: 2012) including Cybersecurity practices and implementation.
  • Background in software quality assurance, software test development, test methodologies and test automation for native applications built QNX or Similar OS.

• Proficient knowledge and skill in Microsoft Office Suite applications.
• Excellent oral written communication skills, critical thinking skills, and project management skills.
• Ability to work conscientiously and with minimal direction, using good judgment, taking initiative to accomplish short and long-range projects, and recommend actions with minimal direction.