Quality Engineer (I/II) (ADX-23-20) at ArcherDX
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QUALITY ENGINEER I/II-IVD (ADX-22-20)
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.
POSITION SUMMARY:
The Quality Engineer, reporting to the Sr. Quality Engineer/Manager Quality Engineering, will implement the Quality Management System (QMS) to ensure in-vitro diagnostic (IVD) medical devices manufactured under Good Manufacturing Practices are in compliance with relevant ISO standards and FDA regulations. The Quality Engineer will also be tasked with understanding the underlying quality issues and implementing continuous improvement activities to ensure that standards are maintained.
RESPONSIBILITIES:
- 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.
QUALIFICATIONS:
- 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
EDUCATION:
- Bachelor's degree in a scientific field
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