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Senior Quality Engineer (Multiple Locations)

Company: Evidation Health
Location: San Mateo
Posted on: February 25, 2021

Job Description:

Senior Quality Engineer (Multiple Locations) *Considering candidates Bay Area, Santa Barbara, and US based remote* 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. E vidation 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. Ability and willingness to multi-task is a must. This is a full-time role, which can be remote or based in San Mateo, CA. 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 BENEFITS
      • Health, dental, and vision benefits for you and competitive coverage for your family
      • Relocation support
      • Equity
      • Open vacation policy - take time when you need it
      • Support for remote work when needed
      • Relaxed work environment
      • Your choice of computing equipment and gear
      • Lots of opportunities for growth
      • Opportunity to work on fascinating challenges that improve people's lives Are you legally authorized to to work in the US --*
        -- Will you now or in the future require sponsorship to work in the US --*
        -- U.S. Equal Opportunity Employment Information (Completion is voluntary) Individuals seeking employment at Evidation are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file. Gender Please select Are you Hispanic/Latino? Please select Race & Ethnicity Definitions If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Veteran Status Please select Form CC-305 OMB Control Number 1250-0005 Expires 05/31/2023 Voluntary Self-Identification of DisabilityWhy are you being asked to complete this form? We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years. Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp . How do you know if you have a disability? You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition. Disabilities include, but are not limited to:
        • Autism
        • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
        • Blind or low vision
        • Cancer
        • Cardiovascular or heart disease
        • Celiac disease
        • Cerebral palsy
        • Deaf or hard of hearing
        • Depression or anxiety
        • Diabetes
        • Epilepsy
        • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
        • Intellectual disability
        • Missing limbs or partially missing limbs
        • Nervous system condition for example, migraine headaches, Parkinson's disease, or Multiple sclerosis (MS)
        • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression Disability Status Please select 1 Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp . PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

Keywords: Evidation Health, San Mateo , Senior Quality Engineer (Multiple Locations), Engineering , San Mateo, California

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