You are passionate about compliance questions as well as audits and gathered a few years of experience with Medical Devices? For our client - a leading pharmaceutical company situated in Zuchwil- we are contracting a:
Compliance Auditor Medical Devices
- Conduct and lead Internal Audit as per company Internal Audit schedule and assess compliance with local, national, international and company regulations, policies and procedures
-Support inspection readiness plan within EU region against EU MDR in high collaboration with site compliance partners and business partners
- Collect metrics data from sites
- Use of tracking and trending tools in order to share proactive trends/signal to the compliance leader
- Support Compliance improvements, which result from audits, Quality Board Issues and other system indicators
- Work effectively with the Source Compliance team and other site compliance specialist to ensure consistent systems across the organization
- Ensure proper internal audit reporting, response review and approvals, communication of issues
- When required assist given facilities for both external audit preparation and assistance during their external audit
- Extensive knowledge of Quality Systems (21 CFR 820/ISO 13485/EU MDR) within a regulated environment
- At least 5 years working experience in a regulated Medical Device industry
- Experience in a quality and/or compliance function as well as leading performing audits is required
- Excellent Communication Skills (written & oral) in English, German would be a plus
- Excellent Team Player
- High Sense of Urgency
- Available to travel (mostly within Switzerland)
This multifaceted project provides the opportunity to apply and increase your expert knowledge in one of the largest pharmaceutical companies worldwide. Also the possibility of contract extension is given. To submit your complete CV including diplomas and references just use the button ‘Apply'. We are looking forward receiving your application today!