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Optima Organizational Solutions is seeking a highly skilled Senior Quality Manager to join our team in Tijuana, B.C. This is a unique opportunity to lead the quality system program of our manufacturing facility, ensuring continuous production of products consistent with established standards and/or customer specifications.
Key Responsibilities:- Administer the quality system program, ensuring 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.
- Develop and implement quality system requirements, ensuring they are adequately defined, developed, and implemented.
- Hold non-conforming raw materials and components at incoming inspection, as authorized.
- Represent the Tijuana facility during FDA, ISO, and customer assessments, as well as scheduled management review meetings.
- Administer the complaints program, reporting and trending activities, and recommend corrective action to preclude recurrence.
- Administer the corrective action program, including problem identification, technical assistance, and monitoring and verification of change effectively.
- Ensure quality systems and regulatory affairs resources are available for verification of quality system.
- Implement quality reporting systems, providing various departmental managers with information regarding quality system performance.
- Review external customer specifications, ensuring they are attainable or warrant process improvement prior to contract agreements.
- Evaluate and dispose of specification change requests, ensuring compliance to quality and regulatory requirements.
- Supervise personnel performance and enhance personnel development within the Company's Quality System and regulatory affairs organization.
- Establish and maintain Device Master Record (DMR) and Device History Record (DHR).
- Develop plans and strategies to ensure positive employee relations and effective communications.
- Direct and monitor records and documentation to ensure 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.
- 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.
- The proven capability to manage a large, diverse department and ability to handle multiple priorities at a given time.
