Process Quality Engineer II/III (PCM) (ADX-131-20) at ArcherDX
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 enhance 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.
The Process Quality Engineer II/III, reporting to the Senior Quality Engineer, will support tech transfer, production scale-up, and Quality operations activities for Personalized Cancer Monitoring (PCM) product development, and implement the Quality Management System (QMS) to ensure ArcherDX medical devices are manufactured under FDA GMP and ISO 13485 regulations. The Process Quality Engineer II/III will also be tasked with developing quality processes in a high-throughput Manufacturing environment, investigating quality issues, and implementing continuous improvement activities to ensure that production rates are scalable while maintaining Quality standards.
- Serves as the Process Quality Engineering representative on new product development and tech transfer projects, and provide strategic Quality representation across teams.
- Influences across Quality System functions, including, but not limited to, design, production, assay development, document control, risk management, etc.
- Develops, implements, and evaluates tools, systems, and methods for product/process improvement and conformance.
- Applies Lean/Six Sigma principles to identify and implement improvements in a rapidly-growing GMP manufacturing environment to increase capacity, reduce lead-time, and improve process flow.
- Collaborates between Development and Production teams to ensure that Quality and Lean are built into manual and automated processes.
- Provides technical guidance and quality compliance for multiple areas of the quality system to ensure process and product quality.
- Identifies and supports quality test methods, inspection criteria, risk assessments, and other processes for new products to ensure compliance to regulatory standards.
- Perform other duties as assigned by supervisor
- Bachelor's degree in an Engineering or Scientific field
- Minimum of 5 years of Quality experience in an FDA-regulated environment
- Minimum Lean/Six Sigma Green Belt certification, preferred
- Recommended ASQ CQE certification, or similar
- Expertise in Quality System requirements, including ISO13485 and 21CFR820
- Ability to communicate and influence cross-functionally
- Ability to apply Lean/Six Sigma and Quality Engineering principles in product development and tech transfer processes
- Attention to detail with a strong ability to create and review technical 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