Quality Assurance Engineer

Location US-MD-Rockville
Posted Date 4 days ago(2/16/2018 4:35 PM)
Job ID
2018-2893
# Positions
1
Company
BioTelemetry, Inc

Overview

Position Summary

The Quality Assurance Engineer is responsible for ensuring compliance and for internal processes associated with the Quality System and quality assurance as part of regulatory compliance requirements and governed by the BioTelemetry Research Quality System Procedures.

Responsibilities

Responsibilities:

  • Performing final product delivery review on external facing customer deliverables
  • Supporting Corporate Supplier Management activity related to clinical trial studies: audits, approved supplier process, inventory and source inspection
  • Managing the Corrective Action process, including customer complaints
  • Monitoring and reporting performances and Quality metrics monthly
  • Supporting the Deviation, Letter-to-File and Audit (Internal & External) processes

Qualifications

Qualifications

 

Education:  

  • Bachelor’s degree in Engineering, Life Science or equivalent

 

Experience:

  • Five (5) years experience in Quality or Regulatory environment
  • Demonstrated knowledge of Good Clinical Practices, GXPs, as well as global regulations
  • Experience in clinical trials, medical device and/or pharmaceutical industry preferred

 

Skills:

  • Mastering Good Documentation Practices
  • Highly developed investigational skills
  • Excellent understanding of 21 CFR Part 11 and other FDA regulatory requirements (especially those associated with clinical trials), GCP and ICH guidelines and directives
  • Ability to work with data spreadsheets, select metrics and identify trends
  • Strong written and verbal communication skills
  • Ability to work in groups and individually with little supervision
  • Computer literacy and training and experience in Microsoft Office products, required

Company

BioTelemetry, Inc

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