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Validation Engineer Job

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Date: Mar 14, 2019

Location: MY

Company: Boston Scientific

Primary Location: [[filter2]]
Additional Locations: (n/a)
Job Function: Quality
Requisition ID: 284302



Validation Engineer, II

Support and maintain the validation system in regards to software validation.

Key Responsibilities:

  • Provide support to the validation department in regards to decisions on what systems requires validation as well as support the validation / remediation of software installed in the company, maintain the change control of the software and provide guidance in IQ creation and execution.
  • Identify areas that may require software validation and advice system owners about validation requirements.
  • Analyze areas for improvement and recommend/advice about software solutions
  • Maintain procedures related to Software Validation; provide support to Process Validations in regards to OQ, PQ, PPQ revisions.



Bachelor’s Degree in Engineering. Expertise in Statistics is highly desirable.


Skills & Experience:

3-5 + Years Medical Device Industry Experience. Experience in these topics are highly valuable: Risk Management knowledge, Statistical Knowledge, Design of Experiments, Minitab experience preferred.

Green Belt/Black Belt (Desirable). Certified Quality Engineer (Desirable). ISO 13485 Certified Auditor (Desirable).



Communication and mediation skills. Being able to guide the team through the procedure and regulation requirements.  Decision Making Skills.



Posting Notes: [[filter2]]||(n/a)||Quality||[[mfield2]]

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