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Overview
Job Description
Responsibilities
Own creation and implementation of all design control deliverables
Lead on-time Design Verification and Design Validation (and support Process Validation IQ/OQ/PQ/PPQ) planning & execution
Actively participate in and contribute to core team and customer facing meetings
Drive meaningful translation of User requirements into discrete, objective, measurable, verifiable, and traceable Product requirements
Oversee risk management activities throughout the device life cycle - from product concept through post launch
Create accurate and repeatable test & inspection methods
Support creation and execution of biocompatibility and sterilization qualifications
Analyze data and prepare product test reports
Oversee content of the Design History File, its completeness and integrity
Ensure component specifications are properly defined and evaluated through the creation of supplied component sampling plans, First Article Inspections and supplier process qualifications
Support supplier management activities and external audits
Support external audit and certification efforts conducted by customers and regulatory bodies
Support manufacturing lines by resolving components issues or other manufacturing barriers in a timely manner.
Oversee and approve document change requests, non-conformances, deviations and special work order processes
Lead root cause analysis and resolution activities
Review and approve equipment specifications and qualification
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Responsibilities
Own creation and implementation of all design control deliverables
Lead on-time Design Verification and Design Validation (and support Process Validation IQ/OQ/PQ/PPQ) planning & execution
Actively participate in and contribute to core team and customer facing meetings
Drive meaningful translation of User requirements into discrete, objective, measurable, verifiable, and traceable Product requirements
Oversee risk management activities throughout the device life cycle - from product concept through post launch
Create accurate and repeatable test & inspection methods
Support creation and execution of biocompatibility and sterilization qualifications
Analyze data and prepare product test reports
Oversee content of the Design History File, its completeness and integrity
Ensure component specifications are properly defined and evaluated through the creation of supplied component sampling plans, First Article Inspections and supplier process qualifications
Support supplier management activities and external audits
Support external audit and certification efforts conducted by customers and regulatory bodies
Support manufacturing lines by resolving components issues or other manufacturing barriers in a timely manner.
Oversee and approve document change requests, non-conformances, deviations and special work order processes
Lead root cause analysis and resolution activities
Review and approve equipment specifications and qualification
#J-18808-Ljbffr