Share this Job

Validation Engineer Job

Apply now »
Apply now

Apply for Job

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.

 

Education:

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).

 

Competencies:

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]]


Job Segment: Developer, Medical, Engineer, Risk Management, Medical Device Engineer, Technology, Healthcare, Engineering, Finance