Senior Quality Engineer Molding - Cardinal Health
Overview
Lead Quality Engineering contributions to ensure regulatory compliance and product excellence. Drive continuous improvement initiatives and mentor team members. Differentiate through ownership of validation processes and cross-functional collaboration.
What You'll Do11
- 1Provide Quality Engineering leadership to Manufacturing Operations and ensure compliance to regulations, procedures, and standards applicable to Cardinal Health
- 2Lead and participate in continuous quality improvement activities
- 3Respond to complaints and non-compliance and sign off on deviations, validation, and other design verification protocols
- 4Ensure on-site lab is testing and escalating issues that arise
- 5Conduct trend analysis with non-conformance compliance and develop month-end reports and management reviews
- 6Develop correctional and preventative actions for quality related processes
- 7Serve as internal auditor and lead external regulatory auditors throughout the facility
- 8Provide leadership and facilitate problem solving, resource utilization, career guidance, coaching, and mentoring of team members
- 9Apply experience in medical device manufacturing, verification and validation of processes and test methods
- 10Coordinate with multifunctional team root cause investigations using analytical and problem-solving skills
- 11Follow safety rules to avoid accidents, occupational diseases, and environmental contingencies within the plant
Requirements6
- 13+ years of QA experience in Molding
- 2Medical device manufacturing experience
- 3Bachelor's degree in related field or equivalent work experience
- 4English proficiency
- 5Understanding of ISO13485 and FDA regulations
- 6Advanced experience in Molding and sustainability
Salary Insight
Salary not disclosed in listing
Location
Required Skills
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