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Senior Software Validation with Medical Device and IEC and ISO Exp

Remote • Posted 1 hour ago • Updated 1 hour ago

Contract W2

Remote

$30 - $40/hr

Fitment

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Job Details

Skills

IEC 62304
ISO 14971
FDA regulations
21 CFR Part 11
GAMP 5
embedded
cloud-based software testing
RTM
traceability
V&V
design documents
test plans
validation protocols

Summary

JOB DESCRIPTION:

We are seeking a Senior Software Validation & Quality Engineer with experience in regulated environments, preferably medical devices. The ideal candidate will support software quality, validation, testing, compliance, and audit readiness.

Key Responsibilities:

Review software requirements, design documents, test plans, validation protocols, and reports.
Support software V&V, functional/integration/system testing, and validation activities.
Maintain requirements traceability (RTM) and verification evidence.
Support risk management, change control, configuration management, and defect investigations.
Participate in design, code, and quality reviews.
Support FDA/ISO audits and regulatory compliance activities.

Must-Have Skills:

4+ years of Software Validation/Quality experience in a regulated environment.
IEC 62304, ISO 14971, FDA regulations, 21 CFR Part 11, GAMP 5
Software V&V, validation protocols, test plans/cases, RTM.
Risk management, change management, and configuration/version control.
Experience with embedded and/or cloud-based software testing.
Strong documentation and cross-functional collaboration skills.
Bachelor s degree or equivalent experience.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 90944144
Position Id: 9102244
Posted 1 hour ago

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Ankit Rai

Recruiter @ Synkriom

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Job Details

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