Location: Boulder CO
Company Name: ArcherDX
Occupational Category: 17-2112.00,Industrial Engineers
Date Posted: 2020-02-08
Valid Through: 2020-03-09
Employment Type: FULL_TIME
Quality Engineer (RUO) (ADX-213-19)
ArcherDX, headquartered in Boulder, CO, is committed to the advancement of personalized medicine by making next-generation sequencing technology more reliable and accessible. We seek like-minded individuals who share our values of curiosity, passion, and grit to meet these goals.
Make it happen by joining us in the fight against cancer.
The Quality Engineer will work in the Research Use Only (RUO) environment and will develop, implement and maintain an appropriate Quality Management System (QMS) in the research and development space. S/He will also assist in transfer activities of processes to the Good Manufacturing Practice (GMP) space.
The Quality Engineer (RUO) will report to the Director of Manufacturing Quality Engineering.
Develop and implement an appropriate QMS for the research and development space
Manage internal RO quality resources
Manage key initiatives by demonstrating accountability to management on timelines, costs, and execution
Maintain adherence to the QMS
Act as a facilitator of risk management (ISO14971:2012) as it applies to the creation of a risk management file for the products in development as appropriate
Support core teams in the planning and transfer of products to the GMP space
Assess and respond to internal and external customer feedback
Act as subject matter expert for the RUO QMS
Participate in resolution of supplier issues
Maintain compliance with all company policies, quality systems, procedures, and ISO and GMP requirements as appropriate
Work with cross-functional teams in problem-solving
Assist in collecting and evaluating data to support quality metrics
5 - 10 years in medical device quality management system implementation and/or management.
Experience working in a research and development quality system environment
Preferred companion diagnostic experience
Demonstrable experience in medical device risk management,
Certifications, such as ASQ, in quality assurance, preferred.
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. Archer is interested in a subject matter expert who will build collaboration among key departments rather than define functional boundaries.
Minimum Bachelor’s Degree in science discipline or equivalent experience