Compliance Engineer

Job type:
on-site
Start:
04/2014
Duration:
n.a
From:
Real Staffing
Place:
Orange
Date:
06/03/2014
Country:
flag_no USA
project ID:
715197

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This project is archived and not active any more.
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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.

Qualifications

Education Experience Requirements:
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