Quality Engineer, IVD (I/II) (ADX-23-20)
THE COMPANY: ArcherDX, Inc. - www.ArcherDX.com
ArcherDX is advancing molecular diagnostics with a robust technology platform for genetic mutation detection by next-generation sequencing. By combining patented Anchored Multiplex PCR (AMP™) chemistry in an easy-to-use, lyophilized format and powerful bioinformatics software, the Archer® platform enhances genetic mutation identification. ArcherDX provides oncology-focused research products and is pursuing regulatory approval for multiple companion diagnostic assays. ArcherDX is headquartered in Boulder, Colorado. Learn more at www.archerdx.com and follow @ArcherDXInc on Twitter, Facebook and LinkedIn.
- Provides quality engineering guidance to ensure process and product quality.
- Leads and drives improvements to R&D manufacturing engineering, production, procurement and others.
- Develops, implements and evaluates tools and equipment for quality assurance and for product/process improvement and conformance.
- Provides floor support to manufacturing. This includes oversight of process areas, documentation, and participation in issue resolution.
- Develops systems for monitoring manufacturing quality. Recommends and assists, as necessary, in the implementation of corrective/preventative actions.
- 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
- Review, understanding, and compliance with ArcherDX HIPAA Security policies and procedures.
- Safeguarding the privacy and security of protected health information and European Union personal data.
- Processing and handling of European Union personal data only as directed by ArcherDX for purposes of personalized molecular pathology.
- Minimum of 3 years of quality engineering, or closely related experience (Level 1)
- Minimum of 5 years of quality engineering, or closely related experience (Level 2)
- Recommended ASQ CQE certification, or similar (Level 1)
- Required ASQ CQE certification or similar (Level 2)
- Knowledge of Quality System requirements, including FDA GMP, ISO13485, and 21CFR820
- Ability to communicate and influence cross-functionally
- 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
- Bachelor's degree in a scientific field