Senior Quality Engineer, Medical Devices

at  Nirsense Inc

Interested applicants please forward 1) Cover Letter, 2) Resume/CV, and 3) Three professional references to Careers@NIRSense.com.
About the Company:
NIRSense is a medical technology company focused on creating world-leading wearable sensor systems to measure brain and muscle oxygenation. We’re a small, dedicated team seeking candidates interested in thoroughly understanding problems, excited about designing devices with broad applicability, and ready to transition those prototypes towards production and commercial use. We’re searching for a fellow enthusiast to play an integral role in expanding our engineering team and capabilities.
Job Summary:
We are seeking a Quality Manager who will be responsible for full ownership of NIRSense’ quality systems. This person will develop and lead our team’s quality maturation with a focus on ensuring company and system compliance with FDA requirements via ISO and IEC safety standards, along with company health and safety procedures, quality training, and workplace safety.
Salary: Compensation package will be commensurate with the successful applicant’s experience. Anticipated hiring range is $105-125k.
Hours: Full Time
Travel: Up to 5%

Minimum Qualifications:

• B.S. or M.S. in an engineering discipline or a related field plus eight (8) or more years industry experience in quality systems management for a medical device company
• Strong knowledge of safety, performance, and regulatory compliance requirements of medical devices, such as IEC 60601, ISO 10993, ISO 13485, ISO 14971, IEC 62366, and related FDA guidance
• Class II medical device quality management experience
• Experience developing and bringing a company’s quality management system online
• Experience representing novel medical devices to the FDA

Preferred Qualifications:

• Experience working with wearable systems
• Prior experience working with startups and with a local network
• Experience managing quality systems for cleared/approved devices during post market surveillance
• Experience liaising with clinical research sites to support ongoing device monitoring

Job Responsibilities:

• Lead quality management system (QMS) activities for NIRSense medical devices, including document control, change management, complaint handling, deviation/CAPA, and team training for quality practices
• Own and lead the modifications of NIRSense’s existing electronic QMS (eQMS) as needed to ensure that device quality and regulatory standards are met, including meeting ISO 13485, ISO 14971, IEC 60601-1, IEC 62304, and ISO 10993 requirements
• Support internal audits of NIRSense quality system
• Support internal and external audits as subject matter expert on QMS lifecycle documentation
• Manage internal and external CAPAs for appropriate action, risk assessment, and effectiveness
• Provide leadership during external audits performed by regulatory bodies such as FDA, government partners, and other customers
• Support the compilation of DHRs, DMRs, and DHFs across the NIRSense product lines
• Lead continuous improvement projects for device development, production, and quality processes
• Keep team apprised of updates to quality documents critical for NIRSense’ systems and operations
• Report to the Director of Engineering

• Lead quality management system (QMS) activities for NIRSense medical devices, including document control, change management, complaint handling, deviation/CAPA, and team training for quality practices
• Own and lead the modifications of NIRSense’s existing electronic QMS (eQMS) as needed to ensure that device quality and regulatory standards are met, including meeting ISO 13485, ISO 14971, IEC 60601-1, IEC 62304, and ISO 10993 requirements
• Support internal audits of NIRSense quality system
• Support internal and external audits as subject matter expert on QMS lifecycle documentation
• Manage internal and external CAPAs for appropriate action, risk assessment, and effectiveness
• Provide leadership during external audits performed by regulatory bodies such as FDA, government partners, and other customers
• Support the compilation of DHRs, DMRs, and DHFs across the NIRSense product lines
• Lead continuous improvement projects for device development, production, and quality processes
• Keep team apprised of updates to quality documents critical for NIRSense’ systems and operations
• Report to the Director of Engineerin