Project Validation Specialist IIIUS
Job Location:
Job Location:
Anasco, us-territories - USA
Monthly Salary:
Not Disclosed
Monthly Salary:
Posted on:
3 days ago
Posted on:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
Job Title: Project Validation Specialist IIIUS
Location (On-site Remote or Hybrid): Anasco PR (Onsite)
Contract Duration: Contract until 01/05/2027
Work Hours: M-F Business Hours
Location (On-site Remote or Hybrid): Anasco PR (Onsite)
Contract Duration: Contract until 01/05/2027
Work Hours: M-F Business Hours
Summary Description:
The position is to support the European Union Medical Device Regulation (EU MDR) program. The incumbent will be supporting the following activities to ensure conformance with EU MDR for technical filing of products manufactured included in the EU MDR program.
The position is to support the European Union Medical Device Regulation (EU MDR) program. The incumbent will be supporting the following activities to ensure conformance with EU MDR for technical filing of products manufactured 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
