QuidelOrtho is seeking an Engineer II to address on-market product quality issues and recommend solutions for their clinical laboratory and transfusion medicine products.
Requirements
- Systems thinking acuity and a keen interest in diving deep into complex product issues and learning different technologies.
- Experience with experimental write-ups and English fluency.
- Basic computer skills (MS Word, Excel, PowerPoint, Outlook etc.).
- Experience with clinical chemistry and/or immunohematology systems.
- Curiosity to deep dive into the details of complex hardware and software systems and discover unanticipated interactions.
- Experience in experimental design and results analysis, including data evaluation and interpretation.
- Demonstrated ability in technical analysis and evaluation of data, including good understanding of basic statistics.
Responsibilities
- Assess failure modes of potential quality issues of a systems nature related to hardware/software, reagents, samples, testing protocol and consumables reported by customers and internal stakeholders.
- Critically examine the interface between hardware and software designs and the performance of on-market chemistry products.
- Learn the operating principles of complex electro/mechanical/software systems and scientific principles of how assays work.
- Conceptualize system design changes to correct product quality issues.
- Analyze data from instruments in worldwide AWS databases. Use knowledge of data analytics and statistics to discern significant trends to assess contribution of potential root causes.
- Assist in designing and conducting laboratory studies to determine root cause of product quality issues for clinical chemistry, immunoassay, and immunohematology applications.
- Document and maintain investigation records and findings as part of an auditable Quality System.
Other
- Minimum of 1-3 years progressive work experience.
- Collaborate with cross-functional representatives in quality, customer support, lifecycle management team, operations and our development partners, to define product issues and deviation from intended performance.
- Present investigative findings to the investigation team and department manager in a way that enables broad dissemination and actionable use of technical knowledge.
- Maintain a safe working environment through the proactive identification of hazards and risks.
- Work cooperatively with others to ensure efficient, timely and quality project outcomes.
