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Quality Assurance Leadership at Cardinal Health
As a key member of the Cardinal Health team, the Quality Assurance Manager will provide strategic oversight and leadership direction over multiple job families or areas of expertise within the Quality Assurance function.
Key Responsibilities
- Manage day-to-day Quality Control functions, including scheduling of inspections, line support, and testing, as well as Document Control and quality-related audits and certifications.
- Partner with site Director and managers to recruit, hire, develop, supervise, and train Quality Control and Document Control personnel, including performance reviews in accordance with Departmental and Corporate practices.
- Define, communicate, and enforce quality policies focused on CAH and external compliance and regulatory requirements.
- Coordinate Quality Assurance functions and activities between departments, determining responsibilities and procedures for ensuring effective performance and achieving objectives.
- Participate in the formulation and establishment of organizational policies and quality procedures for the Quality Control department.
- Participate in and lead systems improvements project teams as required.
- Meet 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.
Qualifications and Requirements
- Bachelor's degree in engineering or sciences.
- 5+ years of quality experience in a related field within a medical industry environment.
- 3+ years of management experience, with 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, and product design and transfer processes USA to MEX or similar.
- Experience managing external Regulatory Agency compliance audits (FDA, ISO13485) highly preferred.
- Ability to travel up to 20%.
- Kaizen, Six Sigma Certification highly preferred.
What We Expect from Our Team Members
- 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.
- Gains consensus from various parties involved.
