Description
A new opportunity has been opened for an experienced auditor in a global medical devices companies, based in their Swiss office to take charge for quality system processes in compliance with ISO13485, FDA QSRs, the EU, MDR and other applicable regulations and standards.Responsibilities:
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.
Support Compliance improvements, which result from audits, Quality Board Issues and other system indicators
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
Requirements
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
Please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.