ISO 13485


Certified or extensive knowledge in ISO 13485

Assist in implementing a Quality Management System (QMS), that complies with ISO 13485

Assist in the Development of a quality assurance manual, policy and procedures that are required to ensure that the company’s processes and products are in compliance with applicable quality standards and requirements

Participate in other QMS efforts such as CAPA, Non conformances, internal audits, change management, customer audits, etc. and assist in maintaining the documentation

Provide support writing SOPs as needed.  Guide Subject Matter Experts in writing and revising documentation required by the Quality Management System.

Partner with department managers to ensure all employees understand the system

Ensure documents are routed, reviewed, approved and obsoleted as required by procedures

Experience implementing ISO 13485 (ensuring full implementation of this standard is expected from existing and to-be-developed protocols)

Experience in a multi-disciplinary environment, with engineering, operations, and business functions

Demonstrated ability to set realistic goals and timetables to execute those goals

Mentor/train team members in the QMS

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Reference number US_EN_99_020569_429207