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Quality Assurance Manager
hace 2 meses
We are seeking a highly experienced Quality Assurance Manager to join our team at Cardinal Health. The successful candidate will be responsible for leading the Quality Control function, ensuring compliance with regulatory requirements, and driving continuous improvement initiatives.
Key Responsibilities- Quality Control Leadership
- Develop and implement quality control strategies to ensure compliance with regulatory requirements.
- Lead a team of quality control professionals to ensure effective execution of quality control processes.
- Regulatory Compliance
- Ensure compliance with regulatory requirements, including FDA and ISO 13485.
- Develop and implement procedures to ensure compliance with regulatory requirements.
- Continuous Improvement
- Identify opportunities for process improvements and implement changes to drive efficiency and effectiveness.
- Collaborate with cross-functional teams to drive continuous improvement initiatives.
- Communication and Collaboration
- Communicate quality control strategies and initiatives to stakeholders, including senior management and external partners.
- Collaborate with production management to ensure alignment with company goals and objectives.
- Education
- Bachelor's degree in engineering or sciences.
- Experience
- 5+ years' quality experience in a related field within the medical industry environment.
- 3+ years management experience - solid leadership and influential partnership skills.
- 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.
- Ability to travel up to 20%.
- Kaizen, Six Sigma Certification highly preferred.
- Opportunities for Growth and Development
- Cardinal Health is committed to the growth and development of our employees.
- Diverse and Inclusive Work Environment
- Cardinal Health is an equal opportunity employer and welcomes applications from diverse candidates.
