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 Senior Quality Engineer (Production/Manufacturing QA), you will support tech transfer, production scale-up, and Quality operations activities for In-vitro Diagnostic (IVD) product development. You will also implement the Quality Management System (QMS) to ensure the company's medical devices are manufactured under FDA, GMP, and ISO 13485 regulations. Through this role you will develop quality processes in a high-throughput manufacturing environment, investigate quality issues, and implement continuous improvement activities to ensure production rates are scalable while maintaining Quality standards.
This role reports to the Manager of Manufacturing Quality Operations - IVD, at our Boulder, CO location.Responsibilities:
Job performance will involve a variety of activities including:
- Serves as the process Quality Engineering representative on new product development and tech transfer projects, and provides strategic Quality representation across teams.
- Influences across Quality System functions, including, but not limited to, design, production, assay development, document control, risk management, etc.
- Develops, implements, and evaluates tools, systems, and methods for product/process improvement and conformance.
- Applies Lean/Six Sigma principles to identify and implement improvements in a rapidly-growing GMP manufacturing environment to increase capacity, reduce lead-time, and improve process flow.
- Collaborates between Development and Production teams to ensure that Quality and Lean are built into manual and automated processes.
- Provides technical guidance and quality compliance for multiple areas of the quality system to ensure process and product quality.
- Identifies and supports quality test methods, inspection criteria, risk assessments, and other processes for new products to ensure compliance to regulatory standards.
- Review, understanding, and compliance with company 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 ArcherDX for purposes of personalized molecular pathology.
- 5+ years of Quality experience in an FDA-regulated environment
- Bachelor's degree in an Engineering or Scientific field
- Expertise in Quality System requirements, including ISO13485 and 21CFR820
- Lean/Six Sigma Green Belt certification, preferred
- ASQ CQE certification, or similar preferred
- Attention to detail with a strong ability to create and review technical documentation
- Ability to interact with multiple subject areas, and communicate clearly and effectively verbally and in writing
- Ability to work independently, and utilize good problem-solving skills
- Ability to multitask and work within a fast-paced dynamic team
In Colorado, 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.