Capa Manager Jobs in Gainesville, GA (NOW HIRING)

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.

Position Summary

The Quality Assurance (QA) Specialist ensures that provisioning, configuration, and kitting of medical devices—mobile phones, tablets, and related equipment—meet all applicable regulatory, quality, and customer requirements. The 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 ISO 13485, ISO 9001, FDA 21 CFR Part 820, 21 CFR Part 11, and HIPAA; maintain audit readiness; support internal, customer, and regulatory audits; ensure adherence to 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; ensure full traceability of serialized devices, IMEI tracking, and asset management; support and maintain Production Part Approval Process (PPAP) documentation such as control plans, process flow diagrams, inspection and test results, first‑article inspections where applicable; review, validate, and maintain Certificates of Compliance (CoC) and supplier quality documentation; ensure incoming materials meet specifications 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), 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, and quality documentation and reporting.

Preferred Qualifications

• Strong experience with ISO 13485 and FDA 21 CFR Part 820.
• Experience with PPAP documentation, supplier quality management, HIPAA compliance, and software/system validation concepts.
• Experience using electronic Quality Management Systems (eQMS) for CAPA management, deviations, and audit tracking.

Key Skills & Competencies

• 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.
• Willingness to work on the production floor as needed.

Nice‑to‑Have / Bonus Skills

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