SENIOR QUALITY ENGINEER

Responsibilities

• Develop and execute test plans, test cases, and test scripts.
• Contribute to software verification plans, perform data and performance analysis, and write of final reports, including test summary reports and defect justifications.
• Generate defect reports and verify correct technical fixes while also investigating / isolating root cause of defects and leading triage meetings.
• Develop and implement quality metrics associated with software development and testing performance.
• Analyze architecture and designs to identify test strategies to provide full test coverage.
• Participate in analysis and refinement of requirements for testability, gaps, and clarity.
• Identify risk management activities to ensure software risk control measures are identified and verified; assist with risk-related documentation, if necessary.

Qualifications

• 8+ years of experience with relevant and recent expertise performing the same or similar type of work as required by the position in compliance with the recognized standards below:
• Strong working knowledge of the requirements of FDA QSRs, ISO 13485, IEC 62304, IEC 60601 and ISO14971.
• Experience supporting medical device development and production release cycles.
• Professional background working in Agile / Scrum development environments.
• Expertise with defect tracking and metrics.
• Hands-on experience with requirements management software such as Helix ALM, Jama or Doors.
• Strong technical writing skills, including development of test methods, protocols, reports.
• Proficient computer skills with applicable software packages such as Microsoft Office, Matlab, Excel, etc.

Preferred Skills

• Possess a complete understanding of software development lifecycle phases.
• Strong analytical and troubleshooting skills.
• Excellent written and verbal communication.
• Risk-based decision making.
• Quality mindset with attention to detail.
• Ability to influence cross-functional teams.