About us: Lucira Health is a startup striving to transform the way infectious diseases are diagnosed. Lucira Health is the first at-home COVID test authorized by the FDA. Our technology is a single-use, user-friendly COVID test kit that can produce a positive or negative result at home within 30 minutes. This technology bypasses centralized medical lab testing and streamlines patient care. Our current areas of focus include COVID and influenza.
As Quality Engineer Tech atLucira Health, Inc., you will be responsible for Quality Engineering and Assurance activities ranging from Incoming Inspection to Supply Chain. This is a hands-on role requiring the application of diversified knowledge of engineering, manufacturing, and supplier management. This position reports to the Supplier Quality Manager.
Primary Job Function:
- Oversee the IQC process, and be responsible for improving/developing measurement methodologies
- Support incoming quality inspections and product lot release activities.
- Coordinate with Supply Chain and Manufacturing on prioritizing lots.
- Oversee and implement quality engineering processes/results with technical team to support activities including manufacturing quality, NCRs, CAPA, and supplier quality.
- Use tools/equipment such as a Caliper, Pin Gage, Height Indicator and a Micro-Vu (CMM Machine) for measurements to ensure everything that is being measured correlates with the engineering drawings.
- Develop/write protocols, coordinate the testing and write reports for verification and validation activities, qualifications activities, IQ/OQs, and gauge R&R studies.
- Work with Manufacturing and Technical Team on special projects and validation activities, and work with cross-functional teams to develop inspections as required.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements.
- Additional duties may be identified by functional management based on the current project/business objectives.
- Education: Technical Degree acceptable but must have prior experience in related field
- Experience: 4+ Years of Quality/Regulatory experience in a medical device regulated industry and demonstrated use of Quality tools/methodologies. Familiarity with Injection Molding and Supplier Controls is preferred
- Demonstrated knowledge of QSR (21 CFR 820) / ISO Quality System (ISO 13485)
- Detail oriented, highly self-motivated, and can demonstrate strong critical thinking skills.
- High verbal and technical writing competencies
- Six-Sigma Methodology (DOE, Process Capability, Gage R&R, etc.) is preferred
- Experience with the Micro-Vu is highly preferred, programming on the Micro-Vu is a plus
Lucira Health is an Equal Opportunity Employer
Individuals seeking employment at Lucira Health are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation.