Responsible to develop and implement the Companys quality system in accordance with applicable regulations. Responsible to implement and manage the Companys internal audit program and CAPA program. The QS Specialist will develop and implement training programs for related areas. Manage the company customer complaint program.
Project a positive and supporting approach to staff on related programs. Train and coach employees on methods to support related programs.
Duties: Develop and implement procedures for compliance to requirements such as ISO 13485, EUs Medical Device Directive, Quality System Regulation 21 CFR Part 820. Manage the corporate quality manual. F low chart processes and systems for inclusion in procedures. Assist other departments in the development and documentation of procedures and processes.
Develop and execute training programs for the QS Regulation, ISO 13485 standard, the Quality Manual, and CAPA program. Responsible to train company personnel to assist in internal audit program.
Manage and execute internal audit program. Report internal quality audit metrics for management review.
Participate in external third party audits representing the quality system.
Manage the CAPA program assuring that CAPA are completed in a responsible manner and within specified time limits including closure and effectiveness. Facilitate CAPA teams as needed and assist departments and employees in the completion of CAPA. Provide positive support and promote teaming with regard to CAPA to assure a positive company response to problem solving. Provide training and coaching on problem solving techniques and methods. Report CAPA metrics for management review.
Manage the customer complaint system including auditing and trending customer input to capture applicable complaints or reportable events. Review complaint results to assure root cause analysis and appropriate and timely customer correspondence. Report customer complaint metrics for management review.
Generate quality reports for review and approval of management.
Qualifications: Requires a bachelor's degree in a related technical field and at least 5 years of experience in the medical device field or in a related area. Familiar with a variety of the field's concepts, practices, procedures and regulations. Quality systems development experience in a medical device industry required. ISO 13485 inspections experience required; and FDA inspections experience a plus. Internal audit program management experience required. CAPA experience required. Organizational planning experience required. Metrics reporting experience required. Quality auditing certification a plus.
Job Training Requirements:
Internal operating procedures related to quality systems management and compliance.
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