Quality Assurance/Regulatory Affairs Manager Presque Isle, ME

SUMMARY OF DUTIES

To develop, implement, coordinate, and ensure the organizations compliance to the scope of the quality management system. To maintain the scope of the quality management system in alignment with the strategic direction of the organization, as instructed, for the devices and products produced, and customers and markets served. To ensure that necessary systems have been established to ensure devices and products are manufactured in compliance with customer, quality management system, regulatory and/or statutory requirements.

ESSENTIAL DUTIES

• Ensures compliance to

ISO9001, EN ISO13485, EU MDD/MDR, MHLW

(Japan) Ministerial Ordinance No. 169, and FDA/cGMP Quality Management System requirements in multiple facilities. Suggests and debates alternative methods and procedures in solving problems and meeting changing market opportunities. Cooperates with top management personnel in formulating and establishing company policies, operating procedures, and goals. Develops initial and subsequent changes of quality management system to delineate areas of responsibility, personnel requirements, and operational procedures. Ensures the timely reporting of the effectiveness of the quality management system, such as weekly, monthly, quarterly, and annual reports, and as required under the scope of the quality management system. Ensures the timely reporting of device quality issues by communicating closely and reporting information to the Director, Quality Assurance and Corporate Regulatory Affairs, as required under the scope of the quality management system. Helps drive and support the

ISO 9001/13485

Internal Audit program. Provides leadership and supervision to the Quality Assurance and Quality Control functions which report to the position, to ensure that the goals and objectives of the organization are achieved. Reviews technical problems and procedures of departments and recommends solutions to problems or changes in procedures. Collaborates with external providers (vendors) to ensure their compliance to quality management system requirements and help to address quality and/or other issues. Helps support compliance activities concerning new devices and/or products to ensure their compliance with customer and/or regulatory requirements. Confers with the applicable departments for manufactured devices and/or products to rectify any complaints, non-conformances and/or other issues. Oversees process, product, and equipment validations for the New Britain, CT facility. Promptly discontinues further processing and/or delivery of non-conforming devices and/or products until the discrepancy or non-conforming condition has been corrected. Reviews technical publications, articles, and abstracts to stay abreast of compulsory standards and regulatory requirements as they relate to the scope of the quality management system and products manufactured in the New Britain, CT facility. Investigates customer complaints, perform root cause analysis, identify corrective and preventive action, and prepare reports for customer submission, in a prompt manner. Designs, implements, and maintains quality management system documentation for the assurance of conformity to customer, quality management system standards, and applicable statutory and regulatory requirements. Ensures that the processes required for the quality management system are established, implemented, and are being effectively maintained. Ensures that the policies, procedures, and work instructions of the quality management system are communicated to the organization. Reports to management on the performance of the quality management system and the need for any actions and/or improvements to maintain its effectiveness. Promotes awareness of customer and/or quality management system requirements throughout the organization. Serves as the company's liaison to external parties on matters relating to the quality management system in the New Britain, CT facility. Performing other duties as assigned.

EDUCATION LEVEL

• Bachelor's degree from four year college or university • At least ten yrs of related experience

EXPERIENCE

• Preferred PhD in field relevant to medical devices covered under the scope of MDD/MDR