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QA Design Control Senior Specialist
Mountain View, CA, United States
Combining web development, computer science, genetics, and informatics, 23andMe is at the forefront of a new era in personal genetics. This is your opportunity to join a talented, ambitious team that is creating truly novel technologies and products that will change the way people see themselves and the world.
In this role as QA Design Control Senior Specialist, you will be an integral member of the quality assurance team whose primary role is to ensure that quality system requirements in relation to medical device design control are effectively established and maintained in accordance with 21 CFR 820, ISO 13485 and other regulations and guidances as applicable.
The ideal candidate possesses a broad base of experience and a high level of technical depth applicable to medical device software design. In this role, you are an advocate for quality and support best quality management and quality design practices. You will work with development teams to encourage agile design concepts in an engaging and positive way.
What you’ll do
- Participate in product development teams as the QA representative.
- Be the site expert on design control processes and best practices. Identify innovative and agile solutions for software design control projects in line with industry best practices.
- Create policies and standard operating procedures to implement effective and agile design control, electronic design history file and risk management file processes.
- Create, review and maintain design control records required for quality and compliance activities.
- Provide guidance and support to the company on document requirements, content and standards.
- Lead or function as part of risk assessment teams to identify product, quality system and compliance requirements.
- Lead or function as part of special project teams to Identify compliance gaps and develop and execute strategies to close gaps in an efficient, technical, and compliant manner.
- Advise Management on quality planning (both short term and long term) supporting and providing diagnosis of quality problems (both internal and external), corrective and preventive action (CAPA) programs and continuous improvement programs
- Participate in the development, implementation and maintenance of the quality system.
- Conduct internal audits to assess compliance to standards and to the internal quality system, including investigation, presentation of observations and findings, and reporting.
- Additional duties as assigned.
We hope you have
- Minimum of a Bachelor's degree in a life science discipline such as chemistry or biology or Computer Science, Software Engineering or related area of study.
- 5+ years relevant experience in quality assurance or design control in a regulated IVD or medical device company.
- Thorough understanding of 21 CFR 820, ISO 13485, IEC 62304, ISO 14971 requirements.
- 6 sigma Yellow or Green belt certification a plus.
- Experience with use and implementation of electronic DHF systems as well as computer system validation a plus.
- Demonstrated ability to articulate risk to product quality and quality system compliance.
- Proficiency in risk analysis tools and techniques (e.g. Hazard Analysis, FMEA, Fault Tree, Pareto diagrams, cause-and-effect diagrams, 5 whys, etc.)
- Tenacious attention to detail and consistency.
- Outstanding communication, presentation and interpersonal skills working within all levels of the organization.
- Able to work independently with minimum supervision.
- Excellent teamwork skills and the ability to interface effectively with a wide range of stakeholders.
- Ability to prioritize and multi-task. Flexibility to support changing assignments and priorities in an independent and reliable manner while maintaining a positive and collaborative attitude.
- Knowledge of computer programming in Python, C++, Ruby, Perl or Java a plus.
- Travel 0 - 10%.
23andMe, Inc. is the leading personal genetics company. Our mission is to help people access, understand and benefit from the human genome. 23andMe has over 2 million customers worldwide with ~85 percent consented to participate in research. 23andMe is located in Mountain View, CA. More information is available at www.23andMe.com.
At 23andMe we value a diverse, inclusive work force and we provide equal employment opportunity for all applicants and employees. All qualified applicants for employment will be considered without regard to an individual’s race, color, sex, gender identity, gender expression, religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws. 23andMe will reasonably accommodate qualified individuals with disabilities to the extent required by applicable law.