Global Quality Internal Auditor - Medical Devices

Global Quality Internal Auditor - Medical Devices

Novocure

Krakow, Poland

This role involves supporting Novocure's inspection readiness, quality system compliance, and administrative activities to meet both internal and external requirements. Responsibilities include timely delivery of assigned tasks, contributing to quality improvement projects, and ensuring alignment with Novocure's Quality Objectives and Code of Conduct. The position focuses on maintaining compliance with the company's Quality Management System and ensuring related documentation adheres to applicable standards.

Your responsibilities:

• Plan, conduct and follow up global internal audits as lead auditor;
• Support annual internal audit plan preparation;
• Support internal audits teams;
• Support training activities to increase quality awareness in relation to audits including creation of training material, review and approval of relevant documents, updating corresponding procedures and conduction of related classroom trainings;
• Provide guidance to project teams and business partners to ensure compliance with company policies and procedures as well as MDR, ISO 13485, FDA 21 CFR Part 820 and MDSAP requirements and applicable laws;
• Contact for quality-related questions in the context of audits by notified bodies, customers and authorities;
• Follow-up of audits performed by notified bodies, customers and authorities;
• Participation in the further development of the quality management system according to applicable standards, regulations and law;
• Monitoring of quality data and metrics on a regular basis to ensure appropriate investigation, corrective and preventive actions, and/or escalation is conducted as required for recurring trends. Analyze process-, product-, test-, and Quality Management System data in terms of improvement opportunities;
• Collaborate on risk analysis and pFMEAs in the course of the Quality Management System;
• Support handling of issues and CAPAs;
• As assigned contributes on updates or creation of Quality System Documents.

Your profile:

• University degree or equivalent in engineering, scientific or related field in medical device or pharmaceutical field;
• At least 3 years practical experience in similar position;
• Qualification(s) and experience as an auditor;
• Experience with QMS requirements for medical devices (preferred), or similar strong regulated areas like pharma;
• Experience in Quality Assurance (preferred for medical devices);
• Sound knowledge of interpretation and implementation of ISO 13485, FDA 21CFR 820, MDR and MDSAP;
• Excellent written and oral communication skills;
• Excellent organizational and time management skills;
• Fluent in English, both written and spoken as this is the primary working language;
• Proficient in Microsoft Office.

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