Senior Quality Systems Specialist

Summary

Join Big Health as a Senior Quality Systems Specialist and play a key role in maintaining our Quality Management System for digital therapeutics. This role involves working closely with the product development team on software design control, risk management, and change control. You will partner with cross-functional groups to ensure audit readiness and collaborate on quality management process improvements. The position offers a high degree of autonomy and the chance to contribute to the development of innovative digital therapeutics. This remote-first role can be based anywhere in the US. Big Health is committed to improving people's lives through digital mental health solutions.

Requirements

• A minimum of 3 years of Quality Management experience (system & design) in medical devices
• Working knowledge of Quality Systems in compliance with national and international regulations including 21 CFR 820, ISO 13485, ISO 14971, EU Medical Device Regulations, and IEC 62304
• Working knowledge of software development tools and processes. Including a good understanding of how Agile Software Development practices work with the FDA Quality System Regulation and ISO 13485 Requirements
• Previous experience supporting significant portions of a medical device quality system and demonstrated use of quality tools/methodologies
• Cross-functional/cross-divisional experience and clear, concise communication skills
• An interest in healthcare and wellness and a passion for directly improving people’s lives
• BA/BS degree in a technical field or equivalent practical experience

Responsibilities

• Serve as quality team representative to cross functional partners and drive design control activities/deliverables for development and maintenance of SaMD products throughout the Software Device Lifecycle
• Facilitate development and maintenance of product design documents including user needs, software requirements specification, design output documents, and design traceability matrices
• Support risk management activities to maintain a comprehensive product risk management file including product hazard analysis/FMEA, use error analysis and risk management report
• Lead quality system related activities and processes per ISO 13485, including complaint handling, CAPA investigation and supplier evaluations, training development and management, etc. to ensure product quality and proper implementation of compliant processes
• Collaborate with internal teams to identify and implement improvements to quality management processes and ensure internal SOPs are compliant with applicable international and local regulations
• Participate in the internal and external audit program as needed
• Identify and drive resolution of quality system issues, ensuring alignment with internal procedures and continuous improvement best practices
• Provide Document Control support to ensure all big health records and documents are captured within the internal eQMS system

Preferred Qualifications

Previous experience in software as a medical device

Benefits

• A generous vacation policy
• Professional development fund
• Flexible working arrangements
• Competitive salary packages including stock options