Quality Engineer - Training and Competency at Invitae
Location: San Francisco, California
Invitae is dedicated to bringing comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Our team is driven to make a difference for the patients we serve. We are leading the transformation of the genetics industry, by making clinical-grade genetic information affordable and accessible to guide health decisions across all stages of life.
Our team is expanding rapidly and we’re looking for people who are passionate about helping improve healthcare to join us.
As the Quality Engineer (T&C), you will support QA Program Operations and serve as the Training and Competency process owner. You will lead, mentor, support and facilitate teams creating training and competency programs for regulated roles.
This position will be on site in an Invitae Core Lab and reports to the Site QA Lead.What you will do:
- Administer the system used for documenting training and competency activities for regulated roles
- Create training materials and provide training to users on system functions and capabilities.
- Monitor, trend, analyze and report T&C program data at Management Review meetings.
- Make recommendations for program improvement based on data, industry or regulatory standards and effectiveness.
- Make recommendations and actively participate in process improvement initiatives associated with the training and competency program.
- Work with teams to establish and ensure they meet the right performance thresholds.
- Work with team leads and team members to streamline training and competency processes.
- Ensure training is completed and appropriately documented for all new and changes to assays, systems, programs and tests prior to implementation in production.
- Create employee training files, periodically audit and work with Leads to ensure records are up to date.
- Audit Continuing Education Program periodically. Work with Leads to ensure all technical staff complete the required CEUs annually.
- Work with Team Leads and Directly Responsible Individuals (DRI) to create and maintain a Training Matrix that will ensure team members are trained on the quality programs they need to successfully complete their jobs.
- Ensure the Training Matrix and training provided meets applicable regulatory and standards requirements (including, but not limited to: CLIA, CAP, NYS, ISO and GxP compliance).
- Assist with internal and external audit activities.
- Maintain compliance with all company policies, procedures, regulations and standards.
- Minimum 5 years experience in Quality Assurance.
- Bachelor’s Degree, Engineering or Science field preferred, with strong technical capability.
- Experience in clinical diagnostic laboratory, medical device or related industry, experience managing or leading a training and competency program with a solid understanding of training and competency regulatory requirements including CLIA, NYS, CAP, ( highly desirable: 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 15189 and ISO 14971)
- Demonstrated knowledge and experience training adult learners in a regulated environment.
- High degree of proficiency with document and presentation creation.
- Proficiency with quality tools such as flowcharts, statistical data analysis, mathematical reasoning.
- Record of developing new skills quickly and applying the takeaways from one area to another.
- Ability and willingness to dig deeper, take ownership of the issue and make a meaningful contribution toward investigation and resolution.
- Organizational skills; ability to handle simultaneous projects.
- A passion for training and education, including a creative drive for employee education with a focus on continuous improvement
- Ability to summarize issues in a clear, succinct, and accurate manner that effectively conveys information to the reader.
- Work with peers throughout the organization and be effective in engaging resources.
By joining Invitae, you’ll work alongside some of the world’s experts in genetics and healthcare at the forefront of genetic medicine. We’ve created a culture that empowers our teams and our teammates to have the biggest impact and to explore their interests and capabilities. We prize freedom with accountability and offer significant flexibility, along with excellent benefits and competitive compensation in a fast-growing organization.
Please apply even if you don’t meet all of the “What you bring” requirements noted. It’s rare that someone checks every single item, it’s ok, we encourage you to apply anyways.
At Invitae, we value diversity and provide equal employment opportunities (EEO) to all employees and applicants without regard to race, color, religion, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.
We firmly believe a diverse workplace is critical to our company success and to better serve our diverse patients. Your input is incredibly valuable. We’d greatly appreciate it if you can take a quick moment to make your selection(s) below. Submissions will be anonymous.