Position: The Quality Systems Manager provides company leadership in the maintenance and improvement of corporate-wide Quality Management Systems and support processes. This position will manage system compliance, documentation, supplier quality and quality systems resources and activities in alignment with QSR, ISO 13485, MDD, ISO 10993 and other regulatory requirements. This position reports to the Head of Quality.
Provide hands-on ownership for the various elements of the Ximedica Quality Management System including corrective and preventive action, customer complaints, nonconforming product, internal audits, etc. to ensure successful performance during third-party audits
Ensure efficient and effective processes and tools are established for compliance to QSR and ISO requirements, and that those processes are continually improved
Provide support to internal functions in the application, maintenance, and improvement of quality systems and department specific processes
Act as the Deputy Management Representative in the absence of the Head of Quality Systems
Act as the quality representative for the various design and development project teams as appropriate
Compile and track appropriate metrics and data to demonstrate Quality Management System compliance
Support Management Review process by compiling, publishing and presenting data as directed by Management Representative (Head of Quality)
Involved in the improvement of quality systems based on established direction and priorities
Other tasks as prescribed by direct supervisor
Requirements: Discreet, flexible, dependable, intelligent, detail-oriented, energetic self-starter with strong communication and organizational skills. The Quality Systems Manager will have a proven ability to multi-task and work independently in a dynamic and entrepreneurial environment. The position requires a minimum of 10 years of experience in a quality management role, ideally in both start-up and corporate environments. Additional qualifications are as follows:
A Bachelor’s degree in Engineering/Business Management or equivalent experience
Ximedica is a product development consultancy with an exclusive focus on the commercialization of medical technologies. Our work in a variety of fields over the last twenty-five years has focused on helping our clients deliver products to market designed with the end user in mind. With a diverse array of specialists and generalists, we are able to support turn-key innovation and product developmen...t for our clients who are leaders in a variety of product categories. Ximedica is an ISO 13485:2012 certified and FDA registered full-service product development firm with offices in Providence, San Francisco, Los Gatos, St. Paul, and Hong Kong.