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Validation Specialist

  • ... Posted on: Nov 26, 2024
  • ... Intellectt INC
  • ... Anasco, Puerto Rico
  • ... Salary: Not Available
  • ... Full-time

Validation Specialist   

Job Title :

Validation Specialist

Job Type :

Full-time

Job Location :

Anasco Puerto Rico United States

Remote :

No

Jobcon Logo Job Description :

Role: Project Validation Specialist III
Location: Anasco, PR - 610
Duration: 12 Months


Job Description:
M-F Business Hours

Summary Description:
The position is to support the European Union Medical Device Regulation (EU MDR) program at Integra A asco, PR.
The incumbent will be supporting the following activities to ensure conformance with EU MDR for technical filing of products manufactured at Integra A asco, included in the EU MDR program.
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

Jobcon Logo Position Details

Posted:

Nov 26, 2024

Employment:

Full-time

Salary:

Not Available

Snaprecruit ID:

SD-CIE-5e525dcd234b81ec2e6857984a5f8d4f75c19dbbc4b42f8276c9a70c6976c9c5

City:

Anasco

Job Origin:

CIEPAL_ORGANIC_FEED

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Role: Project Validation Specialist III
Location: Anasco, PR - 610
Duration: 12 Months


Job Description:
M-F Business Hours

Summary Description:
The position is to support the European Union Medical Device Regulation (EU MDR) program at Integra A asco, PR.
The incumbent will be supporting the following activities to ensure conformance with EU MDR for technical filing of products manufactured at Integra A asco, included in the EU MDR program.
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

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