Senior Quality Systems Engineer

Waltham, MA

Our client is a growing global company with a best-in-class surgical portfolio. If you are seeking an opportunity to make a direct impact on a daily basis in fast-paced, dynamic environment, this is an opportunity you shouldn’t pass up!

Responsibilities

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.

Requirements

• 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 kathy@agilesearchinc.com OR 978/952-6425

For more information, please visit http://www.agilesearchinc.com/

Mar, 26, 2019

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