Quality Engineer - Nonconformity Management

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 (NM), you will support QA Program Operations and serve as the Nonconformity process owner for an Invitae Core Lab site. You will lead, mentor, and facilitate teams performing root cause analysis for product and process CAPA investigations ranging from issue identification to implementation of solutions and effectiveness monitoring.

This position will be on site in San Francisco, CA and reports to the Site QA Lead.

What you will do:

• Represent the nonconformity management process during internal, customer, and regulatory audits and inspections.
• Develop, lead and coordinate CAPA Review Board.
• Ensure CAPA action plans are robust and executed promptly, with the appropriate sense of urgency. Monitor CAPA activities for investigations and action item implementation.
• Train and mentor CAPA owners in all required elements and best practices of CAPA, including containment, root cause analysis, correction, corrective and preventive actions and effectiveness checks.
• Provide training on incident reporting, deviations and corrective actions when there is an update to the program.
• Seek and use information from other departments to determine the appropriate response to issues and regulatory impact.
• Maintain CAPA records in a state of audit readiness.
• Review all incidents to ensure proper actions are taken based on risk level.
• Perform periodic trend analysis and corrective action effectiveness measures of all quality system events and seek opportunities for improvement.
• Monitor, trend, and report nonconformity program data at Management Review meetings.
• Capture lessons learned and process weaknesses as part of daily business to continuously improve the QMS.
• Perform software administration associated with the CAPA process (Jira or other eQMS).
• Maintain compliance with all company policies, quality systems, procedures, and applicable regulatory requirements.

Who you are :

• Minimum 5 years experience in Quality Assurance/Quality Engineering.
• Bachelor’s Degree, Engineering or Science field preferred, with strong technical capability.
• Experience in a clinical diagnostic laboratory, medical device or related industry leading CAPA investigations or a CAPA program.
• Working knowledge of regulations, requirements, and standards including CLIA, CAP, 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 15189 and ISO 14971.

Key attributes:

• Demonstrated knowledge of tools and techniques required to perform detailed root cause analysis and develop thorough/complete investigations.
• 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 substantial contribution toward investigation and resolution.
• Ability to handle simultaneous projects.
• 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.
• Ability to find root cause; ability to review action plans and determine if the actions taken effectively address the issue.

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.

Join us.

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.