Job Description
Descripción y detalle de las actividades
The Quality Engineer is responsible for compliance to procedures and regulations for Manufacturing Controls compliance with 21 CFR 820, ISO 13485, ISO 14971, ISO 14644, 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.
Supports 3rd party audits regarding manufacturing processes
and policies.
Identification and interpretation of recognized standards
for medical manufacturing (e.g. ISO 13485, 21 CFR 820, ISO 14644, etc.).
Assists for various testing planning, execution and
reporting, IQ, OQ, PQ. Verification and Validation of manufacturing processes, equipment and tooling etc.
Participates in the ...
The Quality Engineer is responsible for compliance to procedures and regulations for Manufacturing Controls compliance with 21 CFR 820, ISO 13485, ISO 14971, ISO 14644, 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.
Supports 3rd party audits regarding manufacturing processes
and policies.
Identification and interpretation of recognized standards
for medical manufacturing (e.g. ISO 13485, 21 CFR 820, ISO 14644, etc.).
Assists for various testing planning, execution and
reporting, IQ, OQ, PQ. Verification and Validation of manufacturing processes, equipment and tooling etc.
Participates in the ...
Apply for this Position
Ready to join Confidential? Click the button below to submit your application.
Submit Application