Responsibilities
contribute to the development of annual and long-term strategies for the achievement of product and process quality performance and regulatory compliance objectives in mexico operations.
Recruit, retain, lead and develop employees to ensure a highly motivated team, talent is available to achieve growth and f&p culture is embedded, sustained and developed.
Develop, manage, and report budgets and expenses to ensure operational expenses are optimal.
Develop and maintain relationships within fph plant(s) to ensure that product and process quality and regulatory compliance issues are reviewed and improved upon.
Lead and direct quality engineering, quality control and supplier quality functions to ensure product manufacturing and distribution quality strategies and priorities are communicated, understood and applied to meet company quality objectives and relevant market regulatory acceptance requirements.
Contribute to the development and implementation of the site quality plan, internal and external audit plans, and process improvement plans to ensure quality and regulatory compliance objectives are achieved.
Lead a proactive quality and compliance culture at the manufacturing plant(s) to ensure fph's commitment to product quality and regulatory compliance is demonstrated.
Ensure the execution of internal and external quality system audits at the plant(s) to ensure regulatory compliance is maintained.
Develop, monitor and report on the effectiveness of supplier quality process to ensure actions are taken to assist f&p to achieve its business objectives.
Monitor and review product manufacturing, and distribution quality performance and drive improvement to ensure compliant, effective and efficient processes.
Develop and prepare reports on the progress of strategies and plans to allow effective review by mexico and executive management.
Monitor the external environment to identify and prepare for any changes which may impact f&p's mexico site quality management system(s).
Qualifications
bachelor’s degree or equivalent experience in engineering or science.
Expert knowledge of, and significant experience in, medical device quality management systems, applicable regulatory requirements and product manufacturing and distribution processes.
People management and development experience.
Significant experience in understanding and complying with medical device regulations.
Experience in dealing directly with regulatory authorities.
Financial management skills
regulations (verifiable experience)
qsr (21 cfr part 820), mdr, nom-241, nom-137.
International standards
iso-13485, iso-14971, iso-14644.
English
advanced skills to write, read and maintain fluent conversations.
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