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Validation Engineer : 20-00162
Ref No.: 20-00162
Category: Quality Assurance and Testing
Location: Sunnyvale, California
Primary Skills: Design Control, Documentation, GxP, Validation, Medical Device, Pharmaceutical, Risk Analysis, Failure Modes and Effects Analysis, FMEAs, ISO 13485, ISO 14971, ISO 80002, IEC 62304, FDA GMPs
Duration: Long Term
Contract Type: W2 Only

Responsibilities : 
  • Bachelors Degree in engineering, other technical area or business administration preferred.
  • Strong attention to detail to minimize documentation errors.
  • Ability to understand complex technical information and translate into writing.
  • In-depth understanding of design control best practices and GxP.
  • A minimum 3 years work experience with Design Control or Validation focus within the Medical Device and/or Pharmaceutical Industries are required.
  • Experience writing and reviewing engineering complex technical information and translate (design control) documents, including specifications, test protocols and test reports.
  • Understanding of Design Controls under CFR 820 and IEC 62304 to validate product software applications.
  • Experience in Risk Analysis and Failure Modes and Effects Analysis (FMEAs).
  • Ability to manage challenging assignments and multiple assignments in parallel
  • Assertive, outgoing personality with an ability to work collaboratively within an engineering team.
  • Ability to travel up to 10% of the time.
  • Skilled in the use of Agile (or similar lifecycle management system tool), MKS, ALM Polarion or other requirements management tool.
  • Experience with ISO 13485, ISO 14971, ISO 80002, IEC 62304, and FDA GMPs.
       To follow up with any questions, please contact Vaibhav at 408-512-2355

Akraya is an award-winning IT staffing firm and the staffing partner of choice for many leading companies across the US. We offer comprehensive benefits including Health Insurance (medical, dental, and vision), Cafeteria Plan (HSA, FSA, and dependent care), 401(k) (enrollment subject to eligibility), and Sick Pay (varies based on city and state laws).
 
If this position is not quite what you're looking for, visit akraya.com and submit a copy of your resume. We will get to work finding you a job that is a better fit at one of our many amazing clients.
 
Akraya is committed to equal treatment and opportunity in all aspects of recruitment, selection, and employment without regard to gender, race, religion, national origin, ethnicity, disability, gender identity/expression, sexual orientation, veteran or military status, or any other category protected under the law. Akraya is an equal opportunity employer; committed to a community of inclusion, and an environment free from discrimination, harassment, and retaliation.