Quality Management Director
hace 1 semana
We are seeking a highly experienced Quality Management Director to join our team at Cardinal Health. The successful candidate will be responsible for leading the Quality Control function and ensuring compliance with regulatory requirements.
Key Responsibilities- Manage day-to-day Quality Control functions, including scheduling of inspections, line support, and testing.
- Develop and implement quality policies and procedures to ensure compliance with CAH and external regulatory requirements.
- Coordinate Quality functions and activities between departments, determining responsibilities and procedures for ensuring effective performance.
- Participate in the formulation and establishment of organizational policies and quality procedures for the Quality Control department.
- Lead systems improvements project teams as required, meeting with production management on a regular basis to support goals outlined in the company's operating plan.
- Budgeting, planning, and resource evaluation in line with Zero Base Management initiatives.
- Develop strategies to implement Quality system regulations and continuously improve Quality processes.
- Bachelor's degree in engineering or sciences.
- 5+ years' quality experience in a related field within a medical industry environment.
- 3+ years management experience - solid leadership and influential partnership skills.
- Fully bilingual English/Spanish.
- Strong product manufacturing technical background as well as knowledge of Medical Device Quality System regulations.
- Experience in product manufacturing transfers, facility/line startup, etc.
- Experience in product design and transfer processes USA to MEX or similar.
- Experience managing external Regulatory Agency compliance audits (FDA, ISO13485) highly preferred.
- Able to travel up to 20%.
- Kaizen, Six Sigma Certification highly preferred.
- Manages department operations and supervises professional employees, frontline 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, peer customers, and suppliers at various management levels may interact with senior management.
- Interactions normally involve resolution of issues related to operations and/or projects.
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