Job Description
Descripción y detalle de las actividades
Responsible for compliance to procedures and regulations for Manufacturing Controls of the Products and works within a multidisciplinary product development team to ensure the design intent of products is realized effectively and efficiently, including compliance with 21CFR820, ISO 13485, ISO 14971, MDSAP and MDR. - Provides status reporting regarding manufacturing processes deliverables, dependencies, risks and issues, communicating across teams and to direct management. - Assists in managing all Manufacturing Quality Assurance aspects of multiple related projects to ensure the overall program is aligned to and directly supports the achievement of strategic objectives - Partners with Operations: Receiving inspection, Quality control and supplier quality to ensure a streamlined manufacturing process is maintained. - Supports 3rd party audits regarding manufacturing processes and policies - Provides expertise to the manufacturing and design te...
Responsible for compliance to procedures and regulations for Manufacturing Controls of the Products and works within a multidisciplinary product development team to ensure the design intent of products is realized effectively and efficiently, including compliance with 21CFR820, ISO 13485, ISO 14971, MDSAP and MDR. - Provides status reporting regarding manufacturing processes deliverables, dependencies, risks and issues, communicating across teams and to direct management. - Assists in managing all Manufacturing Quality Assurance aspects of multiple related projects to ensure the overall program is aligned to and directly supports the achievement of strategic objectives - Partners with Operations: Receiving inspection, Quality control and supplier quality to ensure a streamlined manufacturing process is maintained. - Supports 3rd party audits regarding manufacturing processes and policies - Provides expertise to the manufacturing and design te...
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