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 genetic testing affordable and accessible for everyone to guide health decisions across all stages of life.Position summary:
As the Design Quality Engineer, you will serve as an authority on design control project core teams. You will develop processes, author quality documentation, and disseminate expertise via training, mentoring and core team collaboration.
This position is a remote position.Responsibilities:
- Own the design control process by improving upon and executing quality management system documentation. Execution will include collaborating, via review and authorship of documents, with Invitae's core teams development teams in the creation of design quality documentation to support validated product design and submissions to regulatory authorities.
- Act as a facilitator of risk management (ISO14971:2012) as it applies to the creation of a risk management file for the product under development. Utilizing the results of the risk assessment as inputs into the design verification protocols, design validation protocols, supplier stratification and process validations.
- Support core teams in the planning, verification &validation, transfer and product launch.
- SME level support for the Design History File during internal and external audits.
- Where appropriate, lead external resources, such as consultants, on key initiatives by demonstrating accountability to management on timelines, costs and execution.
- Assess project and infrastructure needs to build and execute and organizational plan to ensure adequate support for all of Invitae's product and infrastructure obligations.
- Support diligence audits by pharmaceutical partners (potential and current) as well as quality and regulatory authorities. When assigned findings for closure, demonstrate accountability and a dedication to continuous improvement by resolving issues in a timely manner.
- 10+ years in Quality with 5+ years in the design or development of regulated class II and/or class III IVD/medical devices.
- Bachelor's Degree in a Scientific Field.
- Certifications, such as ASQ, in quality assurance preferred.
- Preferred companion diagnostic design control experience
- Experience in medical device risk management, process validation, supplier development.
- Experience defending design and validation documentation to external auditing authorities.
- Ability to interact with multiple disciplines, and communicate clearly and effectively verbally and in writing.
Our competitive compensation package includes a base salary starting from $85,000. In determining the final salary offered, we will evaluate a specific candidate's geographic location, education, skills, and experience.
Invitae offers a competitive total rewards package, which includes healthcare coverage, 401k, and a broad range of other benefits, outlined below:
- Health, dental, vision, short- and long-term disability, and basic life insurance coverage
- Paid time off, holiday pay, parental leave, and other health and wellness supports
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.