Quality Assurance Manager, Medical Devices
hace 1 semana
Job Description:
OverviewICU Medical is seeking a highly experienced Quality Assurance Manager to join our team. As a key member of the Quality organization, you will be responsible for ensuring compliance with regulatory requirements and quality standards.
Key Responsibilities:- Develop and implement quality assurance programs to ensure compliance with FDA regulations and ISO 13485.
- Conduct audits and investigations to identify areas for improvement and provide recommendations for corrective action.
- Collaborate with cross-functional teams to develop and maintain quality systems and processes.
- Provide training and guidance to employees on quality procedures and regulatory requirements.
- 7+ years of experience in quality assurance or a related field.
- Bachelor's degree in a relevant field such as engineering or life sciences.
- ASQ CQE or CSQE certification required.
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