Global Quality Internal Auditor

Location: Portsmouth, NH, US, 03801 New York, NY, US, 10036

Description:

The Global Quality Internal Auditor will be the primary quality internal auditor for Novocure's Quality Management System. This is a full time, exemp position, reporting to the Senior Quality Assurance Engineer. This role can be fully remote for US based candidates, with domestic and international travel requirements.

JOB SUMMARY:

• 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
• Deputize Quality Assurance Engineers and take over relevant activities based on need
• 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
• Supports the line manager as required and advised in the daily business activities and audit related initiatives
• Collaborate on risk analysis and pFMEAs in the course of the Quality Management System
• 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
• Support annual internal audit plan preparation
• Support internal audits teams
• Follow-up of audits performed by notified bodies, customers and authorities
• As assigned contributes on updates or creation of Quality System Documents
• Contact for quality-related questions in the context of audits by notified bodies, customers and authorities
• Support handling of issues and CAPAs
• Plan, conduct and follow up global internal audits as lead auditor
• Participation in the further development of the quality management system according to applicable standards, regulations and law

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Supporting quality improvement projects as defined by the manager
• In time delivery regarding assigned tasks and responsibilities
• Ensuring the compliance of Novocure Quality Management System and related documentation
• Acting in accordance with Novocure’s Code of Conduct
• Supporting Novocure inspection readiness and compliance
• Fulfilling duties and responsibilities in line with the Quality Objectives and Goals
• Supporting Novocure Quality System Compliance and Inspection Readiness administrative activities
• Ensure activities comply with the applicable Novocure Quality System requirements and external requirements

QUALIFICATIONS/KNOWLEDGE:

• University degree or equivalent in engineering, scientific or related field in medical device or pharmaceutical field
• Qualifications:

• Qualification(s) and experience as an auditor
• At least five years practical experience in similar position
• 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 ISO 19011
• Knowledge:
• Sound knowledge of interpretation and implementation of ISO 13485, FDA 21CFR 820, MDR and MDSAP

• High degree of attention to details and general culture of quality
• Excellent organizational and time management skills
• Fluent in English and preferably German, both written and spoken
• Able to work in a team environment and execute tasks with minimal direct supervision
• Proficient in Microsoft Office
• Excellent written and oral communication skills

OTHER:

• Willingness to travel (about 60%) domestic and itnernational
• Ability to lift 20 pounds

ABOUT NOVOCURE:

Our vision

Patient-forward: aspiring to make a difference in cancer.

Our patient-forward mission

Together with our patients, we strive to extend survival in some of the most aggressive forms of cancer by developing and commercializing our innovative therapy.

Our patient-forward values

– innovation

– focus

– drive

– courage

– trust

– empathy

An Equal Opportunity Employer, including disability/veterans

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