Quality Assurance Engineer

About Alveo

Alveo Technologies is the first company to make molecular detection and diagnostics universally accessible – on the farm, in the field, in the clinic, or in the manufacturing plant – helping prevent or significantly limit the destructive impact of viruses, fungi, bacteria, and other pathogens by detecting earlier at the Point of Need™. Alveo’s rugged and portable, multiplex-capable diagnostic platform employs IntelliSense™, its patented method of direct electrical sensing of nucleic acid amplification to provide affordable, rapid, and accurate results. By enabling early pathogen detection, Alveo helps manage global health, food security, and supply chain resiliency by providing actionable insights at lightspeed. Know Sooner, Act Faster™ with Alveo. For more, visit: https://www.alveotechnologies.com/ 

Alveo Technologies is looking for a Quality Assurance Engineer to support the implementation and monitoring of the organization’s QA processes to ensure products and services meet established quality, reliability, and performance standards. You will assist in QA activities across the product lifecycle, including document review, process validation, and regulatory compliance. 

Key Responsibilities: 

Quality Assurance Systems: 

Maintain and improve the Quality Management System to comply with industry standards (e.g., 21CFR820, ISO 13485, ISO 14971 or applicable regulations). 

Create and revise QA documentation, including Standard Operating Procedures, Work Instructions, and Forms. 

Document Review and Control: 

Review and approve quality-related documents (e.g., specifications, test protocols, validation reports) and customer-facing literature.  

Ensure proper documentation and archiving in the document control system. 

Testing and Verification: 

Collaborate with cross-functional teams to ensure adequate testing of products during development and production. 

Participate in verification and validation activities, including planning, execution, and report preparation. 

Compliance and Audits: 

Support internal and external audits, including preparation and follow-up on findings, ensuring that QA processes adhere to regulatory and customer requirements. 

Ensure that QA processes meet regulatory and customer requirements by monitoring adherence to established processes and procedures. 

Non-Conformance Management: 

Identify and document non-conformances, facilitate root cause analysis, and implement corrective and preventive actions (CAPA) to address issues and improve processes. 

Facilitate root cause analysis and implementation of corrective and preventive actions (CAPA). 

Training and Support: 

Provide QA support and guidance to other departments, ensuring understanding and compliance with quality requirements.  

Provide QA support on the proper use of the electronic quality management system. 

Data Analysis and Reporting: 

Monitor and analyze QA data, such as defect trends, audit findings, training metrics, and CAPA effectiveness. 

Generate reports and presentations for management review. 

UDI/GUDID 

Support and maintain the Unique Device Identification process as new products are brought to market.  

Qualifications 

Education and Experience: 

Bachelor’s degree in Biological Sciences, Biomedical Engineering, or a related field (or equivalent industry experience). 

Minimum of 3-5 years of experience working with quality systems within regulated environments. 

Experience with quality tools such as root cause analysis, statistical process control (SPC), and audit support. 

Solid understanding of ISO 13485, FDA QSR (21 CFR 820), and EU IVDR standards, with a focus on IVD product development, testing, and regulatory compliance. 

Prior experience with IVD product development, testing, and regulatory compliance. 

Previous hands-on experience in manufacturing, testing, or process improvement. 

Strong organizational skills and tenacious attention to detail. 

Proficiency in Microsoft Office Suite and QA-specific electronic quality management systems. 

Strong verbal and written communication skills, with the ability to clearly convey technical concepts to both technical and non-technical stakeholders. 

Ability to work collaboratively in a team-oriented environment.  

Proven ability to effectively prioritize tasks and manage multiple competing priorities and deadlines. 

Salary range for this position is $137,436/yr - $145,600/yr

We are an equal opportunity employer and value diversity at Alveo Technologies. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.