Senior Quality Systems Manager

hace 6 días

San Francisco, Heredia, Costa Rica Te Connectivity A tiempo completo

In this role, you will have the opportunity to work with our Quality and Reliability Engineering Teams to analyze the ability of products and production systems to meet customer and contractual requirements through established reliability factors.

You will design, recommend revisions, and install quality control systems, develop and document analytical methods for establishing reliability of products and their components, and conduct analysis on relative reliability with regards to cost, structure, weight, maintainability, facility of production, and availability of materials and equipment.

This role also involves developing, implementing, and monitoring company environmental safety programs and policies to ensure compliance with federal, state, and local environmental, health, and safety regulations and recommending corrective actions if necessary.

You will be responsible for policies and practices to comply with applicable government regulations and industry requirements related to product environmental compliance, the implementation and management of technical and testing standards and specifications, quality control, and reliability programs governing materials, products, and processes, resulting in the optimization of material and labor, as well as failure analysis, root cause, corrective action, and customer communication.

About the position:

  1. Develop and implement world-class quality processes in the Quality System, in support of business requirements, working closely with site Quality leaders.
  2. As a site matures (such as moving from component manufacturing to finished device manufacturing) lead the development of the site quality system to meet additional requirements.
  3. Ensure that all aspects of QMS sites (Management Reviews, Internal Audits, and Supplier Management, etc.) comply with global quality procedures.
  4. Represent quality in meetings with clients; represent the Global Quality organization and be able to outline the creganna quality system and principles as part of business proposals, QBRs, etc.
  5. Support the implementation of quality electronic systems and other systems that could affect QMS.
  6. Serve as a quality approver on Engineering Change Orders (ECO)/Document Change Orders (DCO), training matrices, and other documents as requested.
  7. Facilitate improvement equipment for quality systems.
  8. Provide recommendations for consolidating, standardizing, simplifying, and establishing systems that meet ISO, FDA (QSR), and customer requirements.
  9. Ensure the applicability of current quality policies, procedures, and objectives, keeping informed about the latest updates/modifications related to relevant rules and regulations.
  10. Plan and execute projects and team activities to facilitate changes in the quality system.
  11. Create and review quality system documentation.
  12. Act as a lead auditor to assess compliance with corporate policies, site procedures, and other applicable regulatory requirements.
  13. Support external audits as needed, which may include assisting with preparation activities, conducting mock audits, supporting main room and backroom activities, and preparing responses.
  14. Support change management and organizational strategy on sites.
  15. Lead/participate in projects that directly support compliance and/or continuous improvement of sites, departmental, and global processes.
  16. Develop solutions for a variety of complex problems of varying scope and complexity where data analysis requires the evaluation of identifiable factors.
  17. Conduct on-site training (GDP, GMP, CAPA, Compliance, etc.).
  18. Maintain a solid understanding of the CAPA system and procedures, drive CAPA compliance, and provide CAPA oversight.

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