Senior Quality Engineer (Multiple Locations)
*Considering candidates in San Mateo, Santa Barbara, or US based remote*
Evidation Health’s Senior Quality Engineer will be charged with supporting operational excellence of Evidation’s quality management system in order to deliver high quality health outcome studies. This role requires a broad range of skills, including, but not limited to, cross-functional communications (internal and external), analysis, problem solving, and project management.
RESPONSIBILITIES
- Engage in the improvement of software development life cycle activities and implementation in compliance with IEC 62304 and IEC 62366
- Collaborate cross-functionally to develop and document product development processes and support software and/or data validation activities
- Collaborate cross-functionally to manage and scale the product release and change-control processes for validated systems
- Own and manage the completion and maintenance of risk management activities
- Lead implementation of new electronic systems, such as complaint management, audit management, or electronic Trial Master Files in conjunction with subject matter experts, to ensure compliance, effective training, roll-out and maintenance
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
- Collaborate with cross functional teams to monitor, document, investigate, and report complaints and quality issues related to studies
- Design, execute, and scale systems which effectively identify and resolve quality issues
- Write and review QMS documentation such as SOPs, work instructions, and procedures
- Support other QMS activities as needed including audits, CAPA investigations, and supplier qualification/management
- Support definition, collection, and reporting of objective key performance indicators across the QMS
- Facilitate inter-departmental process improvement activities
QUALIFICATIONS
- 5+ years of experience in quality engineering preferably in health setting
- Undergraduate university engineering degree required, advanced degree preferred
- Startup experience preferred
- Experience in implementing quality management systems for software product development organizations
- Experience building and scaling processes - comfortable with defining use cases/requirements from scratch, and facilitating conversations across diverse functions to achieve compliant, realistic product development and QMS processes
- Proven ability to develop technical product expertise and effectively collaborate with product/engineering teams
- Ability to deliver in a fast-paced, small company environment, navigate ambiguity while delivering results, and seamlessly adjust workload based upon changing priorities
- Self-motivated and takes initiative
- Fast-paced, team-oriented, and extremely organized with excellent written and oral communication skills
- Eager to partner both internally and externally to build creative solutions
- ASQ CQE or CQSE preferred
- Familiarity with HIPAA, human subjects research, and good clinical practices preferred
ABOUT EVIDATION
Evidation measures health in everyday life and enables anyone to participate in groundbreaking research and health programs. Built upon a foundation of user privacy and control over permissioned health data, Evidation's Achievement platform is trusted by millions of individuals—generating data with unprecedented speed, scale, and rigor. We partner with leading healthcare companies to understand health and disease outside the clinic walls. Guided by our mission to enable and empower everyone to participate in better health outcomes, Evidation is working to bring people individualized, proactive, and accessible healthcare—faster.
OUR VALUES
- Put individuals first
- Challenge each other and state your good intent
- Go fast while maintaining quality and integrity
- Work to win together
OUR BENEFITS & PERKS
- Competitive salary + performance bonus + equity
- Medical, dental, and vision benefits with generous company contribution
- Company-provided life and disability insurance
- 401(k) with company contribution
- Wellness and wearable device reimbursements, mental health benefits, wellness programs
- Employee advisory committee focused around diversity, equity, inclusion, and belongingness
- Distributed teams and flexible work hours
- Take time when you need it: 13 paid company holidays + flexible time off
- Paid parental leave
- Mobile phone, home internet, and home office furniture reimbursements
- Apple laptop and your choice of monitor + noise cancelling headphones
- LinkedIn Learning and other professional growth opportunities
EVIDATION HEALTH VALUES DIVERSITY AND IS COMMITTED TO EQUAL OPPORTUNITY FOR ALL PERSONS WITHOUT REGARD TO RACE, COLOR, CREED, RELIGION, MARITAL STATUS, AGE, NATIONAL ORIGIN OR ANCESTRY, POLITICAL ACTIVITY OR AFFILIATION, PHYSICAL OR MENTAL DISABILITY, MEDICAL CONDITION INCLUDING GENETIC CHARACTERISTICS, MARITAL STATUS, SEXUAL ORIENTATION, GENDER IDENTITY, SEX OR GENDER.