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, FDA regulations and customer expectations. The Quality Engineer will also be tasked with understanding the underlying quality issues and implementing continuous improvement activities to ensure that standards are maintained. This position will work with Quality Engineers in the RUO (Research Use Only), PCM (Personal Cancer Monitoring), and QMS on continuous improvement and other special projects to ensure alignment across all functions.

RESPONSIBILITIES:

• Provides quality engineering guidance and support to all impacted departments to ensure process and product quality and regulatory compliance in IVD.
• Leads and drives quality improvements in IVD and ensures harmonization with RUO, PCM and QMS quality groups
• Develops, implements and maintains quality assurance operations in product receiving, production, quality control, labeling, storage and shipping
• Reviews and approves all validation (process, method, cleaning, equipment, etc.) for IVD
• Leads quality assessments in change control management for IVD
• Provides technical support as needed in IVD non-conformance and QC OOS investigations 
• Assists in driving CAPA related to IVD quality processes 
• Monitors and reports quality operation metrics (KPIs). Recommends and assists as necessary in the implementation of corrective/preventative actions. 
• Participates on project teams and/or working groups as required
• Participates in internal and external audits including providing support during customer and regulatory audits
• Participates in authoring and reviewing regulatory submission documentation as needed 
• Maintains compliance with all company policies, quality systems, and procedures
• Performs other duties assigned by supervisor
• Review understanding and compliance with ArcherDX HIPAA security policies and procedures
• 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