Senior Quality Engineer

Therabody® is the wellness tech leader with a mission to inspire and enable every body and mind to keep moving. Therabody’s product ecosystem includes category-creating innovations in wellness products, proprietary software, digital content, and biometrics that have proven benefits around alleviating stress and pain and enhancing performance and sleep. Not only is it part of our brand ethos to help others, but we are also defining the cutting edge of wellness technology while winning accolades such as Fast Company’s Brands That Matter, Oprah's Favorite Things 2022 and the TIME Best Inventions 2022 award.

Who We’re Looking for:

Reporting to the Quality Systems Manager, the Senior Quality Engineer is responsible for documenting and ensuring all aspects of the developed Quality System achieve their stated goals, meet regulatory requirements, and drive continuous improvement. This position will have a significant level of inter-department collaboration and will serve as a key advisor to those departments to ensure regulatory compliance.

This position will work across all elements of Quality Systems. Within Therabody, Quality Systems is also responsible for Complaint Investigations. This role, under the guidance of the Quality Systems Manager, will be responsible for investigating complaints, overseeing device investigations, and driving continuous improvement as part of Post-Market Surveillance.

Key Responsibilities

• Ensure the compliant execution of the Document Management and Change Control Processes
• Provide oversight to CAPA, Investigation, and Nonconformance Owners to ensure accurate, robust, and timely completion of all phases and requirements
• Provide oversight and guidance to the new Product Design Process, including Risk Management, to ensure each phase of the process is completed in a robust and timely fashion
• Execute Complaint Investigations, participate in Health Hazard Evaluations, and support Medical Device Reporting, and Corrections/Removals as needed
• Provide inputs for all Quality System Elements to Management Review
• Develop processes and suggest techniques to improve product compliance
• Participate in Notified Body and Health Authority Audits as an area Subject Matter Expert
• Collaborate with various departments by sharing information regarding product regulation and compliance
• Other duties as assigned
• Domestic travel may be required up to 10% annually

The Right Person Would Have

• Engineering or Manufacturing background with 5+ years of medical device industry experience, in a quality or design quality capacity
• Prior experience or knowledge of MDSAP is a plus
• Broad knowledge and mastery of ISO 13485:2016, US FDA, and European Medical Device Regulations (MDD and MDR)
• Prior experience with ISO, IEC, and Safety Standards related to electronics and battery powered devices is ideal
• Understanding of global regulatory requirements related to Complaint Handling and Post-Market Surveillance
• Strong organization, communication, and problem-solving skills
• Ability to work across multiple departments, disciplines, and time zones

Therabody is committed to diversity, equity and inclusion. We will not tolerate discrimination in employment, employment-related decisions, or in business dealings on the basis of race, color, genetic information, age, sex, sexual orientation, religion, disability, ethnicity, national origin, veteran status, marital status, pregnancy, or any other legally protected status. We will strive to provide an environment free of discrimination to our team members, customers, guests, and suppliers. We seek contributors from all backgrounds and walks of life to join our team, and we encourage our employees to bring their empowered, passionate, and authentic selves to work every day.