In this role as Senior Quality Engineer Software & CSV, you will be an integral member of the quality assurance team whose primary role is to ensure that quality system requirements in relation to software and computer system validation are effectively established and maintained in accordance with 21 CFR 820, ISO 13485, 21 CFR Part 11, IEC 62304 and other regulations and guidance as applicable.
The ideal candidate possesses a broad base of experience and a high level of technical depth applicable to medical device software design and computer system validation. 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.
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
Leads the strategic development, implementation, application, and continuous improvement of 23andMe regulated IT Systems and medical device software
Ensures 23andMe systems are compliant with regulations, including FDA, EU Annex 11, and other IT related compliance regulations.
Keeps abreast of the evolving regulatory policy and industry best practices related to regulated software and IT Systems.
Advises 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
Identifies compliance gaps and trends and develops and executes strategies to close gaps in an efficient, technical, and compliant manner to improve overall quality performances
Participates in the development, implementation and maintenance of the quality system and ensures compliance with all company policies and procedures.
Reviews off the shelf software, software development tools and software systems used in quality processes to determine appropriate validation requirements
Provides QA input to author, review and finalize quality-related documentation.
Provides oversight and approvals of risk assessments related to IT systems and platforms
Collaborates with functional areas to establish and update metrics that are reported to leadership that highlights risks and key opportunities for continuous quality improvement
Facilitates effective cross-functional communication, alignment, collaboration and execution on IT and software quality-related objectives, plans, and priorities
Works with project managers to establish work scheduling plans in support of project schedules.
Performs other related duties as assigned
We hope you bring
A Bachelor’s degree in Computer Science, Software Engineering, Genetics, Genomics, Molecular Biology or related area of study. Advanced degree is a plus.
Tenacious attention to detail and consistency
Outstanding communication, presentation and interpersonal skills working within all levels of the organization
Ability to prioritize and multi-task
Able to work independently with minimum supervision
Excellent teamwork skills and the ability to interface effectively with a wide range of stakeholders
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.
Strong communication skills
Friendly, flexible and a team player
Innovative thinker and problem solver
Outstanding commitment to customer service and quality
Independent, proactive and self-driven with a can-do attitude
6 sigma Yellow or Green belt certification a plus
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.