Compliance Engineer

Job type:
on-site
Start:
04/2014
Duration:
n.a
From:
Real Staffing
Place:
Los Angeles
Date:
06/03/2014
Country:
flag_no USA
project ID:
715194

Warning
This project is archived and not active any more.
You will find vacant projects in our project database.
Duration: 6-12 month contract to hire

Rate: Open

Start: ASAP

Essential Duties and Responsibilities:
  • Overall responsibility for ensuring that products are developed and tested in compliance with all applicable agency requirements.
  • Understand medical device safety standards (IEC/UL/ES 60601-1) and regulatory requirements, and be capable of identifying those that are applicable for each unique project.
  • Provide Engineering support to Regulatory Affairs to facilitate international product registration.
  • Familiarity with the construction / architecture of product Technical Files, DHF, DMR, and DHR.
  • Interface with Safety Agencies (ETL, UL, CSA, etc.) to coordinate RFQs and work package(s) and providing technical guidance / support during product certification.
  • Provide Support TO RA / QA teams as Engineering Team liaison during FDA, Certification Agency, and ISO audits.
  • Address agency non -compliance issues / audit findings. Owning and Driving closure of the findings.
  • Familiar with CAPA Process and execution.
  • Very knowledgeable with execution of Risk Management Processes, ISO 14971:2007, and associated tools.
  • Compiles, maintains and updates CE tech files including but not limited to PMS reports, Risks, Essentials Checklists and ensuring they remain compliant
  • Design for EMC and Safety Compliance to Domestic and International Agency requirements.
  • Acts as objective evidence/independent reviewer and supports/conducts simulated design validation and R&D verification activities.


Minimum Qualifications:
  • BS in Electrical or Mechanical Engineering or Technical field
  • Minimum 5 years experience in medical device design.
  • Minimum 5 years Product Safety Certification experience is preferred.
  • Solid background in engineering product development and design controls.
  • Strong background in Design Control / DFM / GMP/ FDA / ISO9001/ ISO14971
  • Knowledge of European directives and standards
  • Experience composing memorandums to the FDA


To find out more about Real please visit www.realstaffing.com