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Senior Compliance Engineer : 20-01443
Ref No.: 20-01443
Category: Technician - Laboratory, Manufacturing, Electronics, Electrical
Location: Sunnyvale, California
Primary Skills: Compliance, Regulatory, CAPA, Quality, QMS, Medical Device
Duration:  7 Months (Possible Extension)
Contract Type: W2 Only

Roles and Responsibilities:
  • Provide active support, expertise, during regulatory audits and inspection, which includes practical experience directing the front and/or back room. Facilitate and ensure the successful execution of certification and surveillance audits.
  • Plan and execute efforts to drive regulatory audit recommendations/observations. Ensure that responses are clear, comprehensive, accurate, and well-written to mitigate potential for further regulatory actions.
  • Proactively identify and anticipate risk of non-compliance in a dynamic environment, conformance to regulatory requirements, internal processes and policies. Help track and trend data on common areas of vulnerability.
  • Work with a cross functional team to lead the remediation efforts and ensure resolution.
  • Provide support for continuous improvement of the audit programs, and company-wide inspection readiness.
Requirements:
  • Bachelors’ degree in Engineering or the Physical or Biological Sciences recommended.
  • 5 years in a Quality, Compliance or Regulatory role in the medical device or other regulated manufacturing environment.
  • Min. 3 years of experience managing audits, providing front/back room support
  • Ability to understand the regulations and provide internal interpretation and practical application. Working knowledge of implementing, and providing guidance on domestic and international regulations.
  • Applied understanding of QSR (21 CFR Part 820), ISO 13485, MDSAP, EUMDR. CQE/CQA Certification (Preferred)
             To follow up with any questions, please contact Moiz at 408-816-2442.
 
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.