Description
- Independently conducts assigned audits of Suppliers to assess compliance to all applicable External Standards and Regulations as well internal Quality System requirements at a standard commensurate with regulatory external audits
- Independently conducts and leads audits across supplier and TPM network
- Identifies compliance risks to current standards / regulations and may guide in the planning and execution of Quality System improvements
- Ensures compliance to Division and Corporate policies and procedures by promptly reporting non-compliance issues
- Provides guidance and trains colleagues; provides oversight to one or more junior level auditors
- Leads projects that are cross-functional in scope; directly influences project direction and scope; champions new initiatives and acts as the catalyst for change within and potentially across Divisions
- Maintains and demonstrates understanding of global standards, regulations and regulatory bodies
- May assume managerial responsibilities as needed
- Bachelor's degree in Life Science, Engineering or closely related discipline is required; minimum of 8 years of related experience in the medical device / pharmaceutical industry
- Knowledge of Good Manufacturing Practices (GMPs), Quality System standards and regulatory requirements such as 21 CFR 820; ISO 13485; IVDD; etc.
- Trained in auditing techniques; Certified Auditor qualification or equivalent is required.
If you are interested in this role please contact Oliver Davies at Real Staffing on or apply directly through this advert.