Director of Quality Excellence

hace 5 días

Tijuana, Baja California, México Optima Organizational Solutions A tiempo completo

We are seeking a highly skilled Director of Quality Excellence to join our team at Optima Organizational Solutions. This is an exceptional opportunity for a seasoned quality professional to lead our Tijuana manufacturing facility and ensure compliance with regulatory requirements.

Job Summary

The Director of Quality Excellence will be responsible for managing the quality system program, ensuring continuous production of products consistent with established standards and customer specifications. Key responsibilities include planning, implementing, and directing quality system programs, as well as investigating failures, initiating corrective actions, and monitoring the effectiveness of changes.

Main Responsibilities:

  • Administrates the quality system which meets the requirements of Drug and Device Good Manufacturing Practices (GMPs), ISO 13485 Quality System Standard, and all pertinent aspects of the JPAL.
  • Ensures that quality system requirements are adequately defined, developed, and implemented.
  • Holds non-conforming raw materials and components at incoming inspection.
  • Serves as the Quality System Management Representative for the Tijuana facility during assessments and management review meetings.
  • Administrates the complaints program, including reporting and trending activities, and recommends corrective action to preclude recurrence.
  • Administrates the corrective action program, including problem identification, technical assistance, and monitoring and verification of change effectively.
  • Assures that appropriate quality systems and regulatory affairs resources are available for verification of the quality system.
  • Assures that appropriate quality reporting systems are implemented through the manufacturing organization to provide various departmental managers with information regarding quality system performance.
  • Reviews external customer specifications and ensures that those specifications are attainable or that process improvement is warranted prior to contract agreements or exceptions be taken.
  • Evaluates and disposes all specification change requests, assuring compliance to quality and regulatory requirements, and supports cost-reduction efforts without decreases in customer-recognizable quality expectations.
  • Has the ability to supervise personnel performance and enhance personnel development within the Company's Quality System and regulatory affairs organization.
  • Establishes and maintains Device Master Records (DMRs) and Device History Records (DHRs), and hospital complaint files in accordance with FDA 820.198.
  • Develops plans and strategies to ensure positive employee relations and effective communications are maintained.
  • Directs and monitors records and documentation to ensure adequate information is maintained for review and follow-up.
  • Plans, promotes, and organizes training activities related to the quality system.
  • Supports all programs and initiatives related to the Ethics Code, Company Values, and Sustainability programs.
  • Supports all company Safety, Health, Environmental, and Quality programs and initiatives. Understands and implements the Quality Policy.
  • Completes all training requirements according to the Training Matrix and Quality Management System, trainings identified in the training needs assessment, and attends all training sessions when participation is required.

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 necessary.
  • The proven capability to manage a large, diverse department and ability to handle multiple priorities at a given time is essential.

Estimated Salary: $110,000 - $140,000 per annum, depending on experience and qualifications. We offer a competitive benefits package and opportunities for career growth and development.

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