Senior Quality Engineer (ADX-21-18)

Published:

Feb 13, 2018

Department:

Quality Assurance

Location:

Boulder, CO
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Position Summary

The Senior Quality Engineer, reporting to the Quality Director, will help develop, implement and maintain the Quality Program including Quality Assurance (QA) activities, the Quality Management System (QMS), including quality process and procedures, and programs to establish and ensure compliance with relevant ISO standards and FDA regulations. The Senior Quality Engineer will also be tasked with understanding the underlying quality issues and developing successful fixes, changing practices where necessary to ensure that standards are maintained.

Responsibilities

  • Manage/assist with the development and implementation of quality policies and procedures
  • Perform and host internal and external audits, draft audit reports, and follow up on required actions
  • Implement and oversee the maintenance program for Quality Systems (Deviations, Non-conformance, Corrective and Preventative Actions, etc.)
  • Participate on project teams and/or working groups, as required
  • Maintain compliance with all company policies, quality systems, and procedures
  • Perform other duties as assigned by supervisor

Growth

  • This hire may be transitioned to higher positions within Quality and/or Regulatory Management as experience and skills prove appropriate.

Experience

  • Experience with quality assurance or experience as a quality engineer
  • Minimum 5-8 years' experience with FDA and/or ISO standards and regulations
  • Medical device software requirements
  • Design control experience
  • Attention to detail with an ability to technically create and review documentation
  • Ability to interact with multiple disciplines, and communicate clearly and effectively verbally and in writing
  • Ability to work independently, and utilize good problem-solving skills
  • Ability to multitask and work within a fast-paced dynamic team environment

Education

  • Bachelor's degree in a scientific field

Company Description

ArcherDX, the NGS applications company, is developing and commercializing a novel approach to target enrichment chemistry. Next-generation sequencing technology based on Anchored Multiplexed PCR (AMP™) generates a highly enriched library of gene targets of interest for downstream genomic sequencing. Complemented by proprietary software and readily accessible reports, our technology enables dramatic enhancement in mutation detection speed as well as complex mutation identification and discovery.

Unless otherwise stated, all descriptions above are preferred but not required for our ideal candidate. Consideration will be given for comparable experience. ArcherDX is an Equal Opportunity Employer.

We offer competitive compensation and generous benefits programs. E-mail your résumé in confidence with salary requirements to careers@archerdx.com.


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Principals only. Recruiters, please do not contact this job poster

How to contact us

Address

2477 55th Street, Suite 202

Boulder, CO 80301

Phone

Phone: (877) 771 1093

Phone: (303) 357 9001

All content © 2018 ArcherDX, Inc.

For Research Use Only. Not for use in diagnostic procedures. For Research Use Only. Not for use in diagnostic procedures.