Role Summary: As a Quality Manager, you'll oversee all elements of Quality Assurance at a site, including focus on quality of product as well as the Quality System. This includes product development elements and Design Control, process improvements, critical documentation processes, ensuring compliance with regulatory standards, and ensuring a robust CAPA process. Your role bridges technical and non-technical aspects, contributing to life-changing technology.
Responsibilities: Provides strategic direction and tactical assistance, and support on matters related to regulations, quality systems and quality issues. This job function has accountability for complying with local and global Quality System requirements as applicable to the product portfolio.Provide diligent and fact-based communication to Management team, peers, and quality, regulatory and other functional team members in the organization.Provides technical support and services to Engineering, Research & Development and other cross-functional groups involved in developing, launching, and maintaining products.Works as a member of the local management team to develop and monitor quality objectives., appropriate Quality KPIs, and provide oversight of Quality processes.Serves as the Management Representative for the Quality SystemSupports development of QA personnel through interaction and training to ensure personnel are informed, and that business interactions and processes comply to applicable laws and regulations.Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.Understands and is aware of the quality consequences that may occur from the improper performance of their specific job. Has awareness of defects that may occur in their area of responsibility, and across the business processes of the organization; including product design, verification and validation, manufacturing and testing activities.Qualifications: Bachelor's degree in a relevant field (e.g., Life Sciences, Engineering).Experience in Quality Assurance, Regulatory Affairs, or Product DevelopmentExperience in the In Vitro Diagnostics and/or Medical Device industry
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