Senior Quality Systems Engineer at Big Health
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At Big Health, our purpose is to help millions back to good mental health. We do this through digital
therapeutics - Daylight™ for worry and anxiety, and Sleepio™ for poor sleep. These solutions are fully
automated cognitive and behavioral programs that are as scalable and clinically validated as drugs
(including being backed by 50 published clinical papers including 13 randomized controlled trials). Our
programs harness the intimacy of the human voice and the power of animation to engage and entertain
while delivering complex concepts to help our users overcome their unique mental health challenges.
We are hiring a Senior Quality Systems Engineer to support the Quality Management System operations
and software development activities of digital therapeutics in compliance with international and US
medical device regulations. This role will work closely with the product development team to drive the completion of key software design control, risk management, and change control deliverables for new product development and current on-market products. The role will partner with cross-functional groups to ensure audit-readiness of
multiple facets of the quality management system including complaints/feedback, CAPA/NC closures,
internal audit planning/execution, and supplier evaluation/approval.
We anticipate travel to Big Health's headquarters office in San Francisco as needed to fulfill the essential functions of your role.
What you'll do:
- Serve as quality lead 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.
- Lead risk management activities to drive the completion of a comprehensive product risk management file including development of a risk management plan, product hazard analysis/FMEA, use error analysis and risk management report.
- Provide quality input into evaluation and design of the product in the areas of change control, usability engineering, design verification and validation, problem report resolution, complaint and nonconforming materials investigations, and implementation of corrective and preventive action (CAPA), as required.
- Support 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.
- Participate in interdepartmental initiatives 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
- Perform and complete work with a moderate degree of supervision, recognize and provide solutions to atypical or infrequent issues based on the defined internal procedures
- Provide Document Control support to ensure all big health records and documents are captured within the internal eQMS system.
What you bring:
- 3-5+ 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, IEC 62366.
- 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
- Previous experience in design assurance of new medical device development and leading risk management activities.
- Cross-functional/cross-divisional experience & clear and 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
Life at Big Health:
- Be part of a team that includes clinical psychologists, software engineers, business leaders and even a former professional magician [shh… it’s a secret].
- Surround yourself with the smartest, most enthusiastic and dedicated people you’ll ever meet, but who listen well, learn from their mistakes and when things go wrong, generously pull together to help each other out
- Check out our values - they’re a living, breathing part of our culture
- Enjoy benefits including a generous vacation policy, professional development fund, flexible working locations and more.
- Competitive salary packages including stock options.
Because we are on a mission to bring millions back to good mental health, we believe it’s essential to reflect the diversity of those we intend to serve. We’re an equal opportunity employer dedicated to building a culturally and experientially diverse team that leads with empathy and respect.
Additionally, we will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance. Big Health participates in E-Verify and will provide the federal government with Form I-9 information from all new employees to confirm that they are authorized to work in the U.S. Big Health does not use E-Verify to pre-screen applicants.