Quality Assurance Specialist

Position Summary

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.

Key Responsibilities

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 enhancements in quality systems and operational efficiency.

Training & Production Support

• 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.

Required Qualifications

• 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

Preferred Qualifications

• Strong experience with:
• ISO 13485 (highly preferred)
• FDA 21 CFR Part 820
• Experience with:
• PPAP documentation
• Supplier quality management
• HIPAA compliance
• Software/system validation concepts
• Experience using electronic Quality Management Systems (eQMS), including:
• CAPA management
• Deviations
• Audit tracking

Key Skills & Competencies

• 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

Additional Requirements

• Experience supporting regulatory audits and inspections
• Ability to work with sensitive medical/device data in compliance with HIPAA requirements
• Familiarity with traceability systems and serialized inventory management
• Ability to work on the production floor as needed

Nice-to-Have / Bonus Skills

• Lean / Six Sigma certification
• Experience with ERP and MES systems
• Experience in medical device kitting, logistics, or provisioning operations