Quality Engineer (RUO) (ADX-213-9)
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.
- 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.