Description

You will own manual testing of Non-Product Software (NPS) within medical device environments, ensuring regulatory compliance and quality.

This role is on-site.

Responsibilities

• Develop and execute test plans, test cases, and validation protocols per regulatory requirements.
• Conduct NPS validation activities, including Installation, Operational, and Performance Qualification.
• Maintain requirement traceability using the Requirement Traceability Matrix (RTM).
• Collaborate with QA, IT, and business stakeholders to verify software compliance.
• Document and manage defects using Jira or HP ALM.

Required Skills

• 5+ years of manual testing experience in medical device or healthcare sectors.
• Experience in NPS validation and understanding of the software validation lifecycle.
• Proficiency with Jira and HP ALM for defect tracking and management.
• Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field.
• Strong documentation and cross-functional team coordination skills.
• Ability to work independently in an onsite capacity.

Preferred Skills

• Experience with quality systems software such as TrackWise, MasterControl, or SAP.
• Knowledge of FDA 21 CFR Part 11, ISO 14971, or ISO 13485.
• ISTQB or equivalent QA certification.

Key Skills

Education

Bachelor's degree