Reporting directly to the Sr. Director of Quality, you will use your expertise to support the continuous improvement, oversight and integrity of the Quality Management System.
• Supports the development and maintenance of quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of the QMS complies with regulation, standards and agency guidelines.
• Reviews, analyzes and reports on quality performance and processes and develops corrective actions for recurring discrepancies.
• Submits appropriate metrics and reports to the site quality management and/or to corporate as part of the Management Review process.
• May act as a liaison between the company and various governmental agencies and notified bodies around the world to foster compliance.
• Can be designated Quality Systems Management Representative in place of the VP QA/RA or Sr. Director of Quality Assurance.
• Bachelor’s degree preferred
• Minimum of 5+ years of medical device engineering experience
• Strong audit background, audit facing and audit facilitating
• Knowledge of US and International regulations including 21CFR820, 803, 806, 807 and 11 as well as the Medical Device Directive/ Medical Device Regulation, EN ISO 13485, EN ISO 14971, and other standards applicable to the international medical device industry
• Certified Green or Black Belt preferred
• Experience in nonconforming material and CAPA methodologies/system
• Strong communication, presentation, facilitation, and project management skills
Inquiries and resumes to: Kathy Provost at firstname.lastname@example.org OR 978/952-6425
For more information, please visit http://www.agilesearchinc.com/