Process Quality Engineer

Company: BioFire Diagnostics
Location: San Jose
Posted on: January 26, 2023

Job Description:

The CompanyThe world is facing a medical crisis, bacteria are increasingly evolving resistance to even our strongest antibiotics. The problem is already very real and immediate; for example, bloodstream infection leading to sepsis is now responsible for more than half of all deaths in hospitals and is the most expensive condition treated in hospitals. Sepsis mortality rate increases > 6% every hour without effective antibiotic treatment. Yet, despite the life and death urgency, and healthcare cost impacts, current methodologies require 3 days to determine the correct antibiotic.Specific Diagnostics, a bioMerieux company, has developed a breakthrough solution to rapidly determine the effective antibiotic treatment for bloodstream and other acute infections. Used for bloodstream infection Specific's solution provides results 2 days sooner than existing methods, saving patients suffering from drug-resistant infection.The JobResponsible for ensuring medical devices are developed, manufactured, and tested in accordance with FDA and other regulatory requirements. Implements and enforces policies and procedures that will maintain adherence to FDA Quality Systems Regulations, ISO 13485, and other applicable country regulations. Maintains an active quality presence in manufacturing areas and will continuously strive for quality improvement.Primary Duties

• Participate in regulatory inspections, audits, investigations, and inquiries regarding the control and assessment of manufacturing quality.
• Participate in site Internal audit and compliance review programs.
• Perform data analysis of field complaints and determine when further investigation is necessary.
• Conduct periodic trend reporting of negative quality indicators (nonconformances, scrap, field complaints) and provide trend reports to management as required.
• Serve as quality representative for process risk management activities. Review and revise exiting risk assessments as necessary through analysis of manufacturing and field data feedback.
• Participate and provide quality guidance for supplier changes
• Evaluate quality status of nonconforming material (incoming and in-process). Ensure the disposition of non-conforming materials meet all site and regulatory requirements.
• Review and approve Validations, Verifications, Qualifications, Scientific Studies, and Technical Reports, as required.
• Participate in site CAPA activities, including root cause analysis. Coordinates the implementation of corrective actions and preventive measures and measures effectiveness of action plans.
• Provide input and approval of QC inspection methods as needed.
• Provide quality review/approval for change management activities.
• Review Bill of Material (BOMs), Assembly Procedures, Part Drawings, and Component Specifications for accuracy.
• Monitor manufacturing activities and promote quality through active relationships with manufacturing floor. Monitor, review and approve any planned or unplanned process deviations.
• Ensures complete and correct Device History Records are compliant to quality procedures through review and periodic audits.
• Participate in the development and execution of quality focused training (GMP, risk analysis, nonconformances, deviations, etc.) to reinforce quality mindsets in other departments. Support continuous improvement projects as needed.Qualifications Training and Education BS in scientific or engineering field and a minimum of 5 years' experience in Manufacturing/Quality Engineering/Quality SystemsExperience
• For level 9: BS in scientific or engineering field and a minimum of 5 years' experience (3 years with MS degree)
• For level 8: BS in scientific or engineering field and a minimum of 8 years' experience (5 years with MS degree)
• Competence in the selection and use of Quality Engineering Tools and Techniques.
• Medical Device or other FDA regulated industry experience required
• Must possess effective written and verbal communication skills.
• Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.).
• Must have knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (ISO, QSR, UL, CSA, VDE, etc.).
• Certification in one of the following is desired: CQE, CSQE, CRE, CQA, CBA, or Six Sigma Green Belt.Knowledge, Skills, and AbilitiesMake decisions based on defined guidelines and procedures. Performs a wide variety of inspection and audit root cause analysis and applies problem solving skills to determine root causes and appropriate corrective actions. Is empowered to make decisions impacting product quality, quality records, and deviation resolution.

Keywords: BioFire Diagnostics, San Jose , Process Quality Engineer, Engineering , San Jose, California