Test Engineer (FDA Product Testing & Remediation)
Test Engineer (FDA Product Testing & Remediation)
Posted on :
21-08-2025
Employer Active
1 Vacancy
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Job Description
Job Description:
- The Test Engineer will be responsible for planning executing and documenting product testing activities required for FDA approval compliance and remediation efforts.
- The role ensures that products meet regulatory quality and safety requirements by executing validation protocols analysing test results and supporting remediation of non-conformances.
- Develop execute and document test protocols procedures and reports in alignment with FDA and ISO regulatory requirements (e.g. 21 CFR Part 11 21 CFR Part 820 ISO 13485).
- Conduct functional performance verification and validation testing of products ensuring compliance with design inputs and regulatory standards.
- Support remediation activities by identifying product gaps executing additional testing and providing objective evidence for compliance.
- Perform root cause analysis and support corrective and preventive actions (CAPA) for product issues discovered during testing.
- Collaborate with cross-functional teams (R&D Quality Regulatory Manufacturing) to ensure testing covers all aspects of compliance and safety.
- Maintain accurate test records traceability matrices and defect documentation to support regulatory submissions and audits.
- Ensure test equipment is properly calibrated validated and maintained per FDA and internal quality system requirements.
- Participate in regulatory audits inspections and reviews providing technical support and test evidence.
- Continuously improve testing methodologies and contribute to risk management activities (FMEA hazard analysis).
- Bachelors degree in engineering (Biomedical Mechanical Electrical Software or related field).
- 2 5 years of experience in product testing verification/validation or quality engineering in a regulated industry (medical device pharma diagnostics).
- Working knowledge of FDA regulations ISO 13485 IEC 60601 ISO 14971 and related compliance standards.
- Experience in remediation projects gap assessments and test documentation for regulatory approval.
- Strong analytical and problem-solving skills with attention to detail.
- Hands-on experience with test equipment automation tools and laboratory practices.
- Excellent written and verbal communication skills for preparing regulatory-compliant documentation.
- Experience in FDA submissions (510(k) PMA De Novo) or supporting documentation.
- Familiarity with software testing (21 CFR Part 11 IEC 62304) if applicable.
- Knowledge of risk management and reliability testing methodologies.
- Previous involvement in remediation programs for FDA/Notified Body audit findings.
Employment Type
Full-time
Key Skills
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