Supervisor, Ingeniero de Calidad

• Develop and implement quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications
• Provide leadership and supervision to technical direct reports within the Quality operations function responsible for assigned products and mfg processes
• Manage, develop, train and guide direct reports, quality staff, and site personnel to achieve site quality goals and maintain regulatory compliance
• Transferring product designs to manufacturing (Design Transfers) and Mfg. site-to-site transfers
• Serves as a liaison with Design Engineering/R&D engineering, Medical Safety, Supplier Engineering, and variety of service providing functions on manufacturing and product matters
• Participates and supports the develop of strategies to continuously improve mfg. and product quality and to simplify and optimize processes to increase efficiencies and enhance productivity
• Participates and supports assigned site management representative during Corporate, internal, and external audits
• Participates and supports the implementation of actions for regulatory, customer and corporate audits, and customer technical visits and to provide responses to findings in a timely manner.
• Reporting of KPI metrics and participates in Site Quality Management Reviews
• Responsible for identifying trends and making decisions that affect product to ensure patient safety
• Responsible for participating or leading process validations and product qualifications
• Product and manufacturing process risk assessments
• Dimensioning and tolerancing knowledge and experience
• Test equipment and method development and implementation
• Implementing changes in accordance to change management procedures and regulatory requirements

• Experience with working in large manufacturing medical device plants.
• A bachelor’s degree in an engineering field required, including one of the following: Biomedical engineering, mechanical engineering, chemical engineering, electromechanical engineering, industrial engineering.
• 4+ years of supervisory and leadership experience of professional and technical staff in the medical industry
• Experience leading over 5-10 technical professionals and associate employees.
• Demonstrated knowledge in FDA regulations and ISO 13485 std requirements, and MDSAP certification.
• Demonstrated knowledge of process for risk management of medical devices and ISO standard 14971
• ASQ management and/or quality engineering certification (ASQ CMQ/OE, ASQ CQE), preferred
• Demonstrated knowledge of statistical analysis and methodologies
• Demonstrate project management skills and experience
• Ability to travel up to 30%
• Ability to assume responsibility and work independently with minimal supervision.

• Advance communication and proficiency in English (verbal and written)

• Manages department operations and supervises professional employees, front line supervisors and/or business support staff.
• Participates in the development of policies and procedures to achieve specific goals.
• Ensures employees operate within guidelines.
• Decisions have a short-term impact on work processes, outcomes and customers.
• Interacts with subordinates, peers, customers, and suppliers at various management levels; will interact with senior management.

Cardinal Health