Description

Own software verification and validation for medical device products, ensuring regulatory compliance and quality standards.

This role is on-site.

Responsibilities

• Perform manual testing of product software across document management, ERP, LIMS, and MES environments.
• Develop and execute test plans, test cases, and validation protocols aligned with regulatory requirements.
• Maintain requirements traceability using a Requirement Traceability Matrix (RTM).
• Collaborate with QA, IT, and business stakeholders to verify intended use and compliance.
• Manage defects using JIRA or HP ALM and support audits with comprehensive validation evidence.

Required Skills

• 5+ years of experience in manual testing within the medical device or healthcare domain.
• Experience in NPS validation and understanding of the software validation lifecycle.
• Proficiency with defect tracking tools, including Jira and HP ALM.
• Familiarity with quality systems software such as TrackWise, MasterControl, or SAP.
• Strong documentation and cross-functional communication skills.
• Ability to work independently in an onsite setup.

Preferred Skills

• Knowledge of FDA 21 CFR Part 11, ISO 14971, and ISO 13485.
• ISTQB or equivalent QA certification.

Key Skills

Education

Any Gradute