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. 

As a member of the core labs, quality systems team, this position will be responsible for the Design Control elements that support the clinical laboratories regulatory submissions.

What you’ll do:

• Manage the quality aspects of the design control process; creating, compiling, reviewing and updating design control documents, including Design History Files, Medical Device Records, Design Inputs/Outputs, Design Verification/Validation.
• Collaborate with the applicable Invitae teams to complete  risk assessments which support validated product design and regulatory submissions.
• Utilize the results of  risk assessments as inputs into the design verification protocols, design validation protocols, supplier stratification, and process validations.
• Act as subject matter expert (SME) for the Design History File during internal and external audits.
• Participate as a member of the product development team to ensure that demanding and difficult projects are handled in a cooperative manner.

What you bring: 

• Bachelor’s Degree in a scientific field.
• 8+ years of experience in Quality
• 5+ years of experience in the design or development of regulated class II and/or class III IVD/IVDD/Medical devices
• Working knowledge of FDA 21 CFR Part 820 and ISO 13485 as well as Laboratory Developed Tests and software as a medical device.
• Experience writing and reviewing design control documents (medical device risk management, process validation, supplier development, etc.).

Preferred skills:

•   Professional accreditation, such as ASQ, in quality assurance, preferred

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.  

Join us!

 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 truly believe a diverse workplace is crucial to our company's success and to better serve our diverse patients. Your input is especially valuable. We’d greatly appreciate it if you can take a quick moment to make your selection(s) below. Submissions will be anonymous.

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