Quality Assurance; QA) Specialist

Quality Assurance (QA) Specialist

Stratix Corporation is the trusted advisor for many industry-leading global enterprises, offering the most comprehensive managed services portfolio to help companies operationalize and realize the full value of their mobile investments. Our passion is partnering with businesses to operationalize their mobile investments with high-value services that drive competitive differentiation.

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.

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.

Quality Oversight

• 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.

Regulatory Compliance (Medical Devices)

Ensure compliance with applicable regulatory standards, including:

• 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

Additional responsibilities include:

• Maintaining audit readiness.
• Supporting internal, customer, and regulatory audits.
• Ensuring compliance with established quality management systems and operational procedures.

Documentation & Medical Device Reporting

Create, review, and maintain:

• Device History Records (DHRs)
• Device Master Records (DMRs)
• Batch and lot records

Generate and manage quality system documentation, including:

• Non-Conformance Reports (NCRs)
• Deviation reports
• Audit findings and corrective action reports

Additional responsibilities:

• Ensure full traceability of serialized devices, IMEI tracking, and asset management throughout provisioning and kitting processes.
• Support and maintain Production Part Approval Process (PPAP) documentation, including:
• Control Plans
• Process Flow Diagrams
• Inspection & Test Results
• First Article Inspections (FAI), where applicable
• Review, validate, and maintain Certificates of Compliance (CoC) and supplier quality documentation.
• Ensure incoming materials and components meet specification and regulatory requirements.
• Collaborate with suppliers and internal teams to resolve documentation discrepancies and quality issues.

Risk Management

• 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.

Process Quality Control & Validation

• 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.

Data Integrity & Compliance

• Ensure integrity, accuracy, and security of provisioning data.
• Verify compliance with HIPAA and data handling policies when managing sensitive information.

Continuous Improvement

• Analyze quality metrics and trends to identify improvement opportunities.
• Support Lean and Six Sigma initiatives to improve process performance and compliance.
• Drive…