Beacon Biosignals is hiring a
Quality Assurance Associate

Summary

Beacon Biosignals is seeking a Quality Assurance Associate to work cross-functionally with hardware and software teams, ensuring patient safety, maintaining data integrity, increasing product quality, and meeting regulatory requirements. The role is remote or can be in-person at Boston or New York office hubs.

Requirements

• BA or BS in an applicable discipline
• Minimum of two years of experience working in a quality environment within Life Sciences
• Experience in the medical device and/or pharmaceutical industry with an understanding of the FDA GCPs and CGMP’s, ISO: 13485, 510(k) and CE

Responsibilities

• Assure consistent production quality by providing support for good documentation practices and control
• Prepare quality documentation and reports by collecting, analyzing and summarizing information and trends, including failed processes, recalls, corrective actions, and re-validations
• Validate quality processes by assisting teams in writing and updating quality assurance procedures
• Achieve quality assurance operational objectives by contributing information and analysis to strategic plans and reviews
• Maintain and improve product quality by supporting the completion of product, company, system, compliance, and surveillance audits, and investigating customer complaints

Preferred Qualifications

• Passion for quality and a high attention to detail
• Excellent interpersonal and communication skills
• Problem analysis and resolution skills
• General knowledge of manufacturing processes

Benefits

Robust asynchronous work practices ensure a first-class remote experience