Indotronix is looking to hire a Project Validation Specialist in Anasco, PR for a contract role.
Pay rate is $35/hour
Summary Description:
The position is to support the European Union Medical Device Regulation (EU MDR) program at A asco, PR. The incumbent will be supporting the following activities to ensure conformance with EU MDR for technical filing of products manufactured at A asco, PR.
Data Gathering Participate in the discovery and compilation of required documentation to be evaluated.
Gap Assessments Assess of all manufacturing documentation such as product device master record (drawings, specifications, bill of materials, production router/instructions, procedures, labeling), process flow charts, incoming inspections, in-process inspections, final inspections, validation plans and process validations, among others.
Remediation Plan Perform tasks identified as part of the remediation plan including, but not limited to: validation documentation generation and execution (change control, validation plans, validation protocols, validation closure reports, technical.
