Quality Assurance Analyst II

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About the Company

Biolinq is a venture-backed digital health company developing a wearable biosensor platform that measures biomarkers important to the management of many clinical conditions including diabetes. This dynamic role is a part of a team of engineers and scientists developing a novel intradermal biosensor technology and the associated software data extraction and rendering SDK that will transform the way people manage their metabolic health.

Job Purpose

This is a key role as part of the Quality team interacting with multiple departments at Biolinq. This highly visible role within the Quality department will focus on processing change orders from cross-functional teams of engineers in chemistry, software, hardware, manufacturing, and quality and setting up the required training associated with the document contained within the change orders. They will be responsible for additional document control activities such as assigning document and DHR numbers, organizing and filing records, and logbook control. They may also contribute to the supplier management program and management of NCMR and CAPA events. This role requires significant attention to detail, great communication skills, and the ability and critical thinking skills to prioritize competing projects.

• To be successful as a Quality Assurance Analyst II, you should demonstrate strong attention to detail and have analytical and problem-solving abilities. The ideal candidate must be able to interpret and implement quality assurance standards and provide accurate and comprehensive feedback to colleagues.

Duties and Responsibilities

• Process Change Orders in an electronic quality management system, performing review for compliance to work instructions and working with submitters to revise change orders as required.
• Create and assign training lessons in an electronic quality management system, ensuring the correct documents are attached to the training lessons, creating course quizzes as applicable, and assigning lessons to the appropriate employees.
• Organize, collect and file paper records associated with manufacturing and Quality
• Communicate effectively with multiple teams to prioritize change orders
• Control the assignment and collection of Logbooks
• Assign manufacturing device history record and document numbers
• Conduct in-person training sessions for employees on various topics
• Conduct employee on-boarding training on Quality related topics
• Create and or revise procedures or work instructions in areas of focus
• Conduct investigations as assigned for NCMR or CAPA events
• Contribute to the Supplier Management process; update ISO certificates, update supplier spreadsheet, etc.
• Pull reports for departmental metrics
• Assist the Quality team in hosting external and customer audits
• Other tasks as assigned