Sr. Quality Engineer ADX-21-2018

  • 2477 55th St, Boulder, CO 80301, USA
  • Full-time

Company Description

Are you tired of working at a job where your work feels unimportant? We were too! ArcherDX is a company on the forefront of battling cancer and other genetic diseases utilizing the latest gene sequencing techniques and best-in-class custom software tools. We are pioneering new approaches leveraging molecular diagnostics for the benefit of humanity. As part of a smaller company, your ideas and contributions will have a significant impact on the products ArcherDX produces. 


Job Description

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

Qualifications

QUALIFICATIONS

  • Bachelor's degree in a scientific field
  • 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

Additional Information

Key Attributes

Participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance success of project and maintain strong relationships within all parts of company

-    Strong communication and presentation skills

-    Proven Ability to thrive in a start-up/change oriented environment

-    Self Starter

-   Driven to perform

-    Self-directed: needs little explicit direction 

-    Able to organize and prioritize a diverse set of responsibilities to ensure that focus on growth and success of company is achieved


We offer competitive pay as well as a generous benefits package