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
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