Quality Engineer III

Summary

Join Beacon Biosignals, a leading at-home EEG platform company, as a Quality representative reporting to the VP of quality. This role, located in the US, involves working within cross-functional squads to support new product development and sustaining initiatives for our FDA 510(k)-cleared Dreem EEG headband. You will guide the evolution of hardware quality systems across the product lifecycle, ensuring compliance with internal standards and global regulatory requirements. A key responsibility includes preparing for and leading second- and third-party audits, collaborating with contract manufacturers on quality agreements and validation support. You will help shape robust and efficient quality processes, prioritizing a risk-based approach to compliance. Growth potential to a management position exists.

Requirements

• Minimum of 5 years of experience in a quality environment within the medical device industry
• Proven ability to work autonomously with hands-on problem solving expertise and strong analytical skills
• Certified software quality engineer (CSQE) or Certified Quality Engineer (CQE)
• Working knowledge of key industry standards and regulations, including 21CFR 820, ISO 13485, IEC 60601, and ISO 14971
• Experience working with electro-mechanical devices, including an understanding of general safety testing and performance testing
• Bachelor’s degree in a relevant scientific, engineering, or related field
• A strong intellectual curiosity with the ability to quickly grasp complex concepts, and solve problems
• Exceptional interpersonal and relationship-building abilities
• Strong analytical, organizational, and communication skills, with a demonstrated ability to adapt effectively to changing circumstances

Responsibilities

• Deliver quality guidance that keeps programs moving efficiently and compliantly
• Proactively identify and resolve risks before they impact deliverables
• Help scale our hardware quality systems to meet the needs of a fast-growing hardware offerings
• Build strong partnerships across engineering, operations, and clinical teams

Benefits

• Equity
• PTO