Lead Quality System Engineer

**Work from where you are - considering candidates in San Mateo, Santa Barbara, or US-based remote**

About Evidation

Evidation creates new ways to measure and improve health in everyday life. Built upon a foundation of user privacy and control over permissioned health data, Evidation's consumer 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. Evidation is working to bring people individualized, proactive, and accessible healthcare—faster. Founded in 2012, Evidation is headquartered in California with employees working from around the globe.

Our Center of Excellence Business Unit is looking for a Lead Quality Systems Engineer to join the team! The Centers of Excellence departments offer leadership, best practices, business unit support, and training in focus areas like Engineering, Quality Management/Regulatory, Business Operations, and Design/Brand.

Evidation Health’s Lead Quality Engineer will be charged with supporting operational excellence of Evidation’s quality management system in order to deliver high quality products and services. 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.  Previous experience supporting software products required. 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.

• Lead cross-functional teams to develop and document software product development processes in compliance with IEC 62304 and IEC 62366; automate and streamline compliance processes with product and engineering teams 
• Manage QMS process improvement and development. Write and implement new procedures, harmonize QMS, ensure compliance and review/approve QMS documentation , procedure implementation, and maintenance; write/ review QMS documentation such as SOPs, work instructions, and procedures
• Manage and/or drive quality improvement and  ensure compliance to new or updated requirements or guidance (eg. ISO 9001, 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
• Collaborate cross-functionally to manage and scale software product release and change-control processes for validated systems
• Mentor and train Evidation employees on quality priorities including but not limited to: part 11 compliance, ISO 9001, and general QMS literacy
• 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
• Lead and conduct risk management activities including hazard analysis and/or  FMEAs
• Lead risk management activities including hazard analysis and/or  FMEAs
• Develop, implement, and monitor key performance indicators across the QMS
• Lead and conduct risk management activities including hazard analysis and/or  FMEAs

Minimum Qualifications:

• Undergraduate university engineering degree (or equivalent) required, advanced degree preferred
• 8+ years of experience in quality engineering preferably in health setting
• 5+ years of quality experience in software product setting required(e.g Software Development Life Cycle, Design Control, SaMD, etc.)5+ years of quality experience in software product setting required (e.g Software Development Life Cycle, Design Control, SaMD, etc.)
• Proven experience building and scaling product development/QMS processes; comfortable defining use cases/requirements and facilitating cross-functional conversation to achieve realistic and compliant goals
• Documented success driving continuous quality improvement for software product development organizations
• Works autonomously in alignment with company priorities; able to navigate and prioritize simultaneous projects
• 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

Preferred Qualifications:

• Demonstrated experience with FDA 21 CFR part 11, ISO 9001, (preferred: familiarity with IEC 62304, and IEC 62366)
• ASQ CQE or CQSE preferred
• Ability to deliver in a fast-paced, small company environment, startup experience preferred
• Familiarity with HIPAA, human subjects research, and good clinical practices preferred
• Consulting experience preferred

Evidation Health values diversity and is committed to equal opportunity for all persons without regard to sex (including pregnancy, childbirth or related medical conditions), gender identity, gender expression, race, color, national origin, ancestry, citizenship, age, religion, physical or mental disability, legally protected medical condition, family care status, military or veteran status, marital status, domestic partner status, sexual orientation, genetic information or any other legally protected characteristic.

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