Quality Assurance Specialist
Job Description
Position Summary:
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The Quality Assurance (QA) Specialist is responsible for ensuring that provisioning, configuration, and kitting of medical devices (mobile phones, tablets, and related equipment) meet all applicable regulatory, quality, and customer requirements.
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This role supports production operations by enforcing quality systems, maintaining compliance with medical device regulations, and driving continuous improvement initiatives through root cause analysis, CAPA processes, risk management, and rigorous documentation practices.
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Key Responsibilities:
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Quality Oversight
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- Monitor provisioning, configuration, and kitting operations on the production floor.
- Perform in-process and final inspections to ensure compliance with specifications and quality standards.
- Ensure proper handling, labeling, and traceability of serialized devices and kit components.
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Regulatory Compliance (Medical Devices)
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Ensure compliance with applicable regulatory standards, including:
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- ISO 13485 – Medical Device Quality Management Systems
- ISO 9001 – Quality Management Systems
- FDA 21 CFR Part 820 – Quality System Regulation (QSR)
- 21 CFR Part 11 – Electronic Records and Signatures (as applicable)
- HIPAA – Protection of patient data / PHI
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Documentation & Medical Device Reporting
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Create, review, and maintain:
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- Device History Records (DHRs)
- Device Master Records (DMRs)
- Batch and lot records
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Generate and manage quality system documentation, including:
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- Non-Conformance Reports (NCRs)
- Deviation reports
- Audit findings and corrective action reports
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Risk Management
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- Participate in risk analysis activities aligned with ISO 14971 standards.
- Support development and maintenance of:
- Risk assessments (FMEA – Failure Mode and Effects Analysis)
- Risk control and mitigation plans
- Ensure risks are properly documented, monitored, and updated throughout the product lifecycle.
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Process Quality Control & Validation
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- Identify process deviations and implement corrective actions.
- Support validation and qualification activities for provisioning systems, software, and operational processes.
- Ensure all processes meet regulatory validation and documentation requirements.
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Data Integrity & Compliance
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- Ensure integrity, accuracy, and security of provisioning data.
- Verify compliance with HIPAA and data handling policies when managing sensitive information.
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Continuous Improvement
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- Analyze quality metrics and trends to identify improvement opportunities.
- Support Lean and Six Sigma initiatives to improve process performance and compliance.
- Drive enhancements in quality systems and operational efficiency.
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Training & Production Support
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- Train production personnel on quality standards, SOPs, and regulatory requirements.
- Serve as a quality representative on the production floor.
- Promote a culture of quality awareness and compliance throughout operations.
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Required Qualifications
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- Bachelor’s degree in Quality, Engineering, Life Sciences, or a related field (or equivalent combination of education and experience).
- Minimum of 2 years of Quality Assurance experience in:
- Medical device manufacturing (preferred), or
- Other highly regulated manufacturing environments
- Hands-on experience with:
- Root Cause Analysis (RCA)
- CAPA systems and processes
- Quality documentation and reporting
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Key Skills & Competencies:
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- Strong analytical and problem-solving skills
- Knowledge of medical device regulations and compliance frameworks
- Experience with PPAP, CoC, and supplier quality controls
- Excellent documentation and reporting capabilities
- Strong attention to detail and data integrity
- Effective cross-functional communication and collaboration skills
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