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Senior Recruiter - Meet Recruitment, Medical Device Division
Position Overview
A contract opportunity is available for an experienced Software Tester with a background in validating scientific or laboratory software in regulated environments. This role involves ensuring the quality and compliance of laboratory informatics systems (e.g., LIMS), with a strong emphasis on risk-based testing, documentation, and regulatory alignment. The ideal candidate will possess both technical software testing skills and a clear understanding of standards that govern clinical or diagnostic software systems.
Key Responsibilities:
Testing & Validation
- Partner with developers, product stakeholders, and QA personnel to clarify requirements and translate them into comprehensive test documentation.
- Design and execute test plans and test cases covering manual and automated workflows (e.g., functional, regression, system, and integration testing).
- Test core lab system modules such as sample intake, tracking, barcode handling, and lab equipment interfaces.
- Ensure traceable, risk-aligned test coverage that supports requirements and compliance objectives.
Compliance & Documentation
- Ensure testing processes adhere to applicable quality and regulatory standards (e.g., 21 CFR Part 11, ISO 13485, IVDR, CLIA, CAP).
- Create and maintain traceability between test artifacts, risk controls, and design documents.
- Contribute to risk management deliverables such as hazard analyses and FMEAs.
- Assist in drafting and reviewing validation documentation (protocols, summary reports, etc.) for internal and external audits or filings.
- Stay informed on evolving standards related to data protection and information security (e.g., HIPAA, GDPR, SOC II).
Required Qualifications
- Minimum of 3 years in software QA or validation, ideally in lab informatics or scientific software.
- Deep understanding of the software development and validation lifecycle in regulated environments.
- Hands-on experience with QA documentation and processes supporting clinical or diagnostic applications.
- Familiarity with regulatory frameworks and standards including 21 CFR Part 11, GxP, ISO 14971, and related guidance.
- Strong communication and analytical skills; ability to work cross-functionally.
Preferred Qualifications
- Bachelor’s degree in Computer Science, Biology, Engineering, or related field.
- Knowledge of automated test tools (e.g., Selenium, Postman, Robot Framework).
- Proficiency with test case and defect management platforms (e.g., JIRA, TestRail).
- Experience supporting LIMS deployment or tailoring workflows to lab needs.
Seniority level
Seniority level
Mid-Senior level
Employment type
Employment type
Contract
Job function
Job function
Engineering and Information Technology
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