Lead Digital Health Quality Engineer

📋 Description

• Serve as representative on cross-functional SaMD and Digital Health Software product development
• Author, review, and approve QMS and project documentation — including risk management files — to
• Lead quality process improvement initiatives, support regulatory characterization and audit, and
• Responsible for compliance with applicable Corporate and Divisional policies, procedures, and
• Perform design control and risk management activities (including cybersecurity risk management) per
• Experience with Computer Software Assurance (CSA) and GAMP5 principles for software validation and

🎯 Requirements

• Bachelor’s Degree with 6 years of experience; or Master’s Degree with 5 years of experience; or PhD
• Experience in coordination and planning of complex activities and ability to identify and resolve
• Experience in a quality systems environment, or equivalent combination of work experience
• Exercises considerable latitude in determining the objectives of and approach of assigned work.
• Strong understanding of regulations and standards affecting software medical devices such as IEC
• Experience with creation and maintenance of QMS documents for development of medical devices.

🎁 Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick)
• Eligible to participate in short-term incentive programs.