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Quality Assurance Document Control and Training Lead
Sunnyvale, California, United States
23andMe is seeking a motivated individual to oversee the process of document control and training. You should be familiar with US FDA regulations and international requirements, including Canada and the EU.
In this role as QA Document Control and Training Lead, you will be an integral member of the quality assurance team whose primary role is to ensure that medical device quality system requirements are effectively established and maintained in accordance with 21 CFR 820, ISO 13485 and other regulations and guidances as applicable. Come join 23andMe!
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
- Lead the company document control and training programs.
- With the guidance of leadership, manage the electronic Document Management System and Learning Management Systems.
- Determine and implement document control best practices across the company and ensure compliance to standards, guidances and to the internal quality system.
- Identify innovative and agile processes and improvements for the training program in line with industry best practices.
- Process document change control records and ensure compliance to standards, guidances and to the internal quality system.
- Maintain policies and standard operating procedures to implement effective and compliant document control and training processes. Ensure quality records are adequately organized, filed and archived.
- 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.
- Collaborate with functional areas to establish and update metrics that are reported to leadership that highlights risks and key opportunities for continuous quality improvement.
- Provide leadership and oversight for junior members of the QA team.
- Provide guidance and support to the company on document requirements, content and standards.
- 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.
- Participate in the development, implementation and maintenance of the quality system.
- Support the implementation of electronic document and training management systems for other 23andMe constituencies.
- Assist in the preparation and management of internal and external audits (e.g. document readiness and retrieval).
What you’ll bring
The ideal candidate possesses a broad base of experience and a high level of technical depth applicable to medical device software. In this role, you are an advocate for quality and support best quality management and quality assurance practices.
- Bachelor’s degree in a Life Sciences discipline or equivalent. Advanced degree is a plus.
- 5+ years relevant experience in document, change control and training in a medical device or regulated company.
- Working knowledge of 21CFR Part 11 requirements and computer system validation concepts.
- Working knowledge of regulatory requirements.
- Proven ability to balance customer service and compliance needs.
- Ability to manage multiple projects with aggressive timelines.
- Detail oriented and strong written and verbal communication skills.
- Ability to work independently or as a team member.
- Demonstrated ability to follow detailed directions in a regulated environment.
- Must be familiar with Microsoft Office (Word, Excel, Power Point) and Adobe (Reader/Creator) applications and electronic document management system(s).
- Experience with implementation and management of an electronic document management system and electronic learning management system a plus.
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 Sunnyvale, 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