• Medical QA Auditor Heredia Province
  • HCLTech in Heredia Province, Heredia, Costa Rica
  • jobs
  • 1 month ago

jobs description


The position of Quality Auditor will support the top leading industry customer around the world. This role will participate in ensure compliance to company/divisional policies and procedures and with FDA and ISO requirements by reviewing non-conformances and audit findings in order to coordinate corrective action.

This individual will contribute as part of team to promote a culture of quality during the QMS integration of several Process Transfers. The ideal candidate will value culture as much as technical skill and work with minimum supervision and has appreciable latitude for implementing actions.

• Supports and leads development of the Regulatory Compliance Strategy for the IM/EM transfer.
• Assists on assessments (internal or at supplier) to identify any opportunities to reduce compliance risk.
• Responsible for the Integration of the Audit Program (procedures, training and system, i.e. ETQ) for IM/EM sites as applicable.
•... Escalates/Communicates any risk identified in the project execution, quality and regulatory compliance related risks or opportunities to appropriate management level.
• Participates in the project meetings as Regulatory Compliance Representative.
• Supports the internal audit program that ensures quality management systems are operating in compliance; develops and manages audit plans; conducts audits, develops metrics and compiles data on auditing results, issues, trends and corrective actions and presents to senior management.
• Supports/Leads readiness activities for audits/inspections by Health Authorities, Notified Bodies or Enterprise Regulatory Compliance.
• Research emerging regulatory trends and changes in regulations and standards to incorporate into the business to ensure ongoing compliance to these requirements.

• 3 years of experience as QA auditor or related.
• Proficient with Microsoft Word, Problem Solving Methodologies and Quality tools such as (but not limited to): root cause analysis, FMEA, 5 why’s, and Ishikawa diagrams.
• BA/BS degree in science, engineering, health-related discipline or any other technical discipline
• 3 years of sustaining or developing Medical Devices experience.
• At least an English Level B2 (70%-79%).

• Certified as Quality Auditor.
• Any ASQ (American Society of Quality) certification.
• Any RAPS (Regulatory Affairs Professional Society) certification.
• Master's Degree in Medical Devices or any other Medical Devices related master or certification.
• Experience on Product Lifecycle Management tools, specially PTC Windchill.
• Proficient in medical domain knowledge and awareness of ISO 13485, ISO 14971 and FDA Quality System Regulations and the ability to apply that knowledge with an understanding of business operations to achieve regulatory compliance, design transfer and process control.
• 2+ years as Project lead
Heredia Province Heredia Costa Rica


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