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 Quality Engineer (CAPA), you will support the quality system and serve as the CAPA process owner for the Invitae Oncology site in Boulder, CO. 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. Your focus will be on supporting risk assessments compliant to ISO14971:2012.Responsibilities:
- Representing the CAPA process during internal, customer, and regulatory audits and inspections.
- Developing, leading and coordinating CAPA Review Board.
- Ensuring CAPA action plans are robust and executed promptly, with the appropriate sense of urgency. Monitoring CAPA activities for investigations and action item implementation.
- Working with all levels of management to ensure CAPA action plans are supported and that costs/resources needed to implement the plan are available.
- Training and mentoring CAPA owners in all required elements and best practices of CAPA, including containment, root cause analysis, correction, corrective and preventive actions and effectiveness checks.
- Seeking and using information from other departments to determine the appropriate response to issues and regulatory impact.
- Maintaining CAPA records in a state of audit readiness.
- Performing periodic trend analysis and corrective action effectiveness measures of all quality system events and seeking opportunities for improvement.
- Monitoring, trending, and reporting CAPA program data for Management Review meetings.
- Capturing lessons learned and process weaknesses as part of daily business to continuously improve the QMS.
- Performing software administration for Arena (eQMS) associated with the CAPA process.
- Maintaining compliance with all company policies, quality systems, procedures, and ISO and GxP requirements.
- Review, understanding, and compliance with Invitae HIPAA Security policies and procedures.
- Safeguarding the privacy and security of protected health information and European Union personal data.
- Processing and handling of European Union personal data only as directed by Invitae for purposes of personalized molecular pathology.
- Minimum 2 years experience in a Quality role. Level I - II - III dependent on experience.
- Bachelor’s Degree, Engineering or Science field preferred, with strong technical capability.
- Experience in medical device, pharmaceutical or related industry with a solid understanding of the CAPA process and its potential to drive quality improvement.
- Working knowledge of appropriate global regulations, requirements, and standards such as 21CFR Parts 803, 806, and 820, ISO 13485, and ISO 14971.
- Demonstrated knowledge of tools and techniques required to perform detailed root cause analysis and develop strong 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 meaningful contribution toward investigation and resolution.
- Organizational skills; ability handle simultaneous projects.
- Writing skills; ability to summarize issues in a clear, succinct, and accurate manner that effectively conveys information to the reader.
- Effective interpersonal skills; work with peers throughout the organization and be effective in engaging resources.
- Analytical skills – Ability to find root cause; ability to review action plans and determine if the actions taken effectively address the issue.
Our competitive compensation package includes a base salary starting from $84,400. 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.