**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 leadership and communication, process improvement,  problem solving, and project management. Ability to collaborate with stakeholders across the organization is a must. Success in this role requires adaptability and flexibility to meet new and changing priorities. This is a full-time role, which can be remote or based in San Mateo, CA.

RESPONSIBILITIES

  • Lead cross-functional teams to develop and document software product development processes in compliance with IEC 62304 and IEC 62366 
  • Collaborate cross-functionally to manage and scale software product release and change-control processes for validated systems
  • Lead and conduct risk management activities including hazard analysis and/or  FMEAs
  • 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
  • Drive quality improvement projects to include compliance to new or updated requirements or guidance (eg. ISO9001, ICH E6(R2), FDA 21 CFR 820, etc.)
  • Establish and cultivate an extensive internal support network to facilitate inter-departmental process improvement initiatives and cross-functional quality investigations 
  • Lead CAPA efforts, and apply sound, systematic problem-solving methodologies identifying, prioritizing, communicating and driving resolution of quality issues (e.g., 5 whys, Is-Is Not, etc.)
  • Collaborate with cross functional teams to monitor, document, investigate, and report complaints and quality issues related to studies
  • Develop, implement, and monitor key performance indicators across the QMS
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
  • Define process and write/ review QMS documentation such as SOPs, work instructions, and procedures

QUALIFICATIONS

Minimum Qualifications:

  • Ability to deliver in a fast-paced, small company environment, startup experience preferred
  • Highly flexible: able to navigate ambiguity and shifting priorities while delivering results
  • Natural collaborator; eager to partner both internally and externally to build creative solutions
  • Proven ability to develop technical product expertise and effectively collaborate with product/engineering teams
  • Self-motivated and takes initiative
  • Extremely organized with strong problem-solving and analytical skills
  • Excellent verbal and written communication skills
  • Demonstrated understanding of FDA 21 CFR 820, ISO 9001, IEC 62304, and IEC 62366
  • ASQ CQE or CQSE preferred
  • Familiarity with HIPAA, human subjects research, and good clinical practices preferred
  • 6+ years of experience in quality engineering preferably in health setting
  • Undergraduate university engineering degree required, advanced degree preferred
  • Proven experience building and scaling product development/QMS processes; comfortable defining use cases/requirements and facilitating cross-functional conversation to achieve realistic and complaint goals
  • Documented success driving continuous quality improvement for software product development organizations

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.

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