Quality Assurance Associate

What you will be doing: 

Beacon Biosignals is looking for a Quality Assurance Associate to work cross functionally with our hardware and software teams. Quality Assurance at Beacon is multifaceted. Its main aim is to help the organization ensure patient safety, maintain data integrity and efficiently increase product quality, while ensuring that all applicable regulatory requirements are met. Beacon views Quality Assurance as a force multiplier and a critical piece to successfully advancing our mission. 

Our robust asynchronous work practices ensure a first-class remote experience, and we also have in-person office hubs available located in Boston and New York.

What success looks like: 

• 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
• Leverage compliance expertise and experience in the life sciences industry to provide guidance across the organization
• Establish and cultivate a strong working relationship across the company to advance the culture and effectiveness of a synchronized approach to quality management

What you will bring: 

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