Quality Director
hace 4 semanas
Optima Organizational Solutions is seeking a Quality Director to oversee the implementation of quality system programs at their Tijuana manufacturing facility. The ideal candidate will have a strong background in quality assurance and regulatory compliance, with experience in managing quality systems and ensuring continuous production of products consistent with established standards and/or customer specifications.
**Key Responsibilities:**
Develop and implement quality system programs to ensure compliance with FDA QSR CFR Title 21:820 and ISO 13485 Quality System Standard requirements.
Manage and coordinate the implementation of quality system programs, including failure investigation reporting, corrective action initiation and tracking, and monitoring the effectiveness of changes.
Administer the Tijuana manufacturing facility quality system, ensuring that quality system requirements are adequately defined, developed, and implemented.
Collaborate with cross-functional teams to ensure quality system requirements are met prior to product release.
Develop and implement corrective action programs, including problem identification, technical assistance, and monitoring and verification of change effectively.
Ensure that quality systems and regulatory affairs resources are available for verification of quality system.
Develop and implement quality reporting systems to provide various departmental managers with information regarding quality system performance.
Evaluate and dispose of all specification change requests, ensuring compliance to quality and regulatory requirements, as well as supporting cost-reduction efforts, without decreases in customer-recognizable quality expectations.
Supervise the performance of personnel and enhance personnel development within the Company's Quality System and regulatory affairs organization.
Establish and maintain Device master Record (DMR); Device History Record (DHR).
Develop plans and strategies to ensure positive employee relations and effective communications are maintained.
Direct and monitor records and documentation to ensure that adequate information is maintained for review and follow-up.
Plan, promote, and organize training activities related to the quality system.
Support all programs and initiatives related to the Ethics Code, Company's Values, and Sustainability programs.
Support all company Safety, Health, Environmental, and Quality programs and initiatives. Understand and implement the Quality Policy.
Complete all training requirements according to Training Matrix and Quality Management System, trainings identified in the training needs assessment, and attend all training sessions when participation is required.
Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position.
**Requirements:**
Bachelor's degree in Engineering or one of the physical sciences.
Master's degree in Business Administration or one of the physical sciences is preferred. ASQ Certifications are recommended.
Working knowledge of statistics is required.
Computer literacy and a working knowledge of GMPs, ISO standards for quality systems, and JPAL are required.
The proven capability to manage a large, diverse department and ability to handle multiple priorities at a given time.
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