Description

You will own manual testing of Non-Product Software (NPS) within medical device environments.

Responsibilities

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

Required Skills

• 5+ years of manual testing experience in medical device or healthcare.
• Experience in NPS validation and understanding of the software validation lifecycle.
• Proficiency with Jira and HP ALM.
• 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