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Sr. Quality Engineer (Design Control)
Mountain View, California, 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 building truly novel technologies and products that will change the way people see themselves and the world.
In this role as Sr. Quality Engineer, 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 and risk management 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 the best quality management and quality design practices. You will work with development teams to encourage agile design concepts in an engaging and positive way.
Who We Are
Since 2006, 23andMe’s mission has been to help people access, understand, and benefit from the human genome. We are a group of passionate individuals pushing the boundaries of what’s possible to help turn genetic insight into better health and personal understanding.
What You’ll Do
- Participate in product development teams as the QA representative.
- Identify creative and agile solutions for software design control projects in line with industry best practices.
- Maintain and develop policies and standard operating procedures to implement effective and agile design control and risk management file processes.
- Build, review and maintain design control records required for quality and compliance activities.
- Provide guidance and support to project teams 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
- Additional duties as assigned.
We Hope You Bring
- 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.
- Deep understanding of and experience working within 21 CFR 820, ISO 13485, IEC 62304 and ISO 14971 requirements.
- Demonstrated ability to identify and articulate risk to product quality and processes.
- Proficiency in risk analysis tools and techniques (e.g. Hazard Analysis, FMEA, Fault Tree, Pareto diagrams, cause-and-effect diagrams, 5 whys, etc.)
- Proven ability to develop technical understanding of product functionality.
- Tenacious attention to detail and consistency.
- Excellent communication, presentation and interpersonal skills working within all levels of the organization.
- Able to work independently with minimum supervision.
- Excellent partnership skills and the ability to interface effectively with a wide range of stakeholders.
- Ability to prioritize and multitask. Flexibility to support changing assignments and priorities in an independent and reliable manner while maintaining a positive and collaborative attitude.
- 6 sigma Yellow or Green belt certification.
- ISO 13485:2016 Lead Auditor Certification
- Experience with use and implementation of electronic DHF systems.
- Practical understanding of human factors and usability engineering
- Knowledge of computer programming in Python, C++, Ruby, Perl or Java.
23andMe, Inc. is the leading consumer genetics and research company. Our mission is to help people access, understand and benefit from the human genome. The company was named by MIT Technology Review to its “50 Smartest Companies, 2017” list, and named one of Fast Company’s “25 Brands That Matter Now, 2017”. 23andMe has over 5 million customers worldwide, with ~85 percent of customers 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 workforce 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. If you are unable to submit your application because of incompatible assistive technology or a disability, please contact us at firstname.lastname@example.org. 23andMe will reasonably accommodate qualified individuals with disabilities to the extent required by applicable law.
Please note: 23andMe does not accept agency resumes and we are not responsible for any fees related to unsolicited resumes. Thank you.Back