Reliability and Compliance Specialist

hace 6 días

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

The ideal candidate will have a strong background in quality assurance and a proven track record of developing and implementing world-class quality processes in the Quality System.

Responsibilities will include leading the development of the site quality system to meet additional requirements as the site matures, ensuring that all aspects of QMS sites comply with global quality procedures, representing quality in meetings with clients, and serving as a quality approver on Engineering Change Orders (ECO)/Document Change Orders (DCO).

The successful candidate will also have experience in process compliance and auditing, problem-solving, and research skills, and be able to manage multiple tasks and accomplish them in a timely manner.

A solid understanding of the CAPA system and procedures, drive CAPA compliance, and provide CAPA oversight is also essential.

About the position:

  • Develop and implement world-class quality processes in the Quality System, in support of business requirements, working closely with site Quality leaders.
  • 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.
  • Ensure that all aspects of QMS sites (Management Reviews, Internal Audits, and Supplier Management, etc.) comply with global quality procedures.
  • 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.
  • Support the implementation of quality electronic systems and other systems that could affect QMS.
  • Serve as a quality approver on Engineering Change Orders (ECO)/Document Change Orders (DCO), training matrices, and other documents as requested.
  • Facilitate improvement equipment for quality systems.
  • Provide recommendations for consolidating, standardizing, simplifying, and establishing systems that meet ISO, FDA (QSR), and customer requirements.
  • Ensure the applicability of current quality policies, procedures, and objectives, keeping informed about the latest updates/modifications related to relevant rules and regulations.
  • Plan and execute projects and team activities to facilitate changes in the quality system.
  • Create and review quality system documentation.
  • Act as a lead auditor to assess compliance with corporate policies, site procedures, and other applicable regulatory requirements.
  • Support external audits as needed, which may include assisting with preparation activities, conducting mock audits, supporting main room and backroom activities, and preparing responses.
  • Support change management and organizational strategy on sites.
  • Lead/participate in projects that directly support compliance and/or continuous improvement of sites, departmental, and global processes.
  • Develop solutions for a variety of complex problems of varying scope and complexity where data analysis requires the evaluation of identifiable factors.
  • Conduct on-site training (GDP, GMP, CAPA, Compliance, etc.).
  • Maintain a solid understanding of the CAPA system and procedures, drive CAPA compliance, and provide CAPA oversight.

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