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.

Job 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.
• 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
  

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical and medical device companies.

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