Quality Compliance Specialist
A fantastic opportunity has arisen for a Compliance Specialist in Solothurn. This position will partner with Compliance leaders from the EU region to ensure overall compliance through internal audit process.
- 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
Skills and 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 - German would be a plus
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical and medical device companies.