10 days old

Quality Engineer II - Cypress, United States - USA 2019-060

DiaSorin
Cypress, CA 90630
  • Job Code
    USA 2019-060
Job Scope

Your Mission

Responsible for evaluating and optimizing manufacturing, QC, R&D and CAPA processes to improve product consistency and to increase productivity.
Responsible for reviewing, performing, and documenting validations for new and existing products.
Supports all applicable regulations including but not limited to FDA, ISO, and CMD/CAS requirements

Main Responsibilities

Your Contributions

Review of design, manufacturing, purchasing, and test documentation to ensure quality requirements are fulfilled.
Review specifications, operation instructions, sheets, process procedures, test procedures, inspection and test analysis.
Provide leadership in and employ advanced quality planning techniques (FMEA, Capability Studies, Measuring and Test Equipment Studies, Product Validation and Reliability Test)
Determine process/equipment capabilities.
Develop and control implementation of SPC techniques
Develop process flow diagrams and perform gap analyses on current controls versus required controls.
Analyze and investigate the root cause of external and internal non-conforming products.
Assist in corrective and preventive actions and verifications of effectiveness such as actions for customer complaints, internal audits, and internal and external suppliers non-conformance.
Perform assessments for process-related risks.
Develop inspection procedures and justified sample plans.
Gather, analyze, and report data reflecting status of product and process and provide recommendation to improve.

Qualifications Experience Personal Strengths Mobility

You

Education

Bachelor's Degree

Specialization

Engineering

Experience

Bachelor's degree preferred in an engineering discipline such as Mechanical, Electrical or Industrial Engineering.
Three-five years related experience in IVD, medical, pharmaceutical, or other related industry.
Must have a thorough understanding of statistical quality control, statistical process control, Corrective Action Process, and their application manufacturing as a problem identification and resolution tool.
Proficient in Advanced SPC, Quality Analysis Tools (Taguchi, Fishbone) & DOE.
FDA Process Validation Techniques preferred
Software product development experience within the IVD environment a plus.

Technical Competencies

Proficient in Advanced SPC, Quality Analysis Tools (Taguchi, Fishbone) & DOE.
FDA Process Validation Techniques preferred

Skills

Quality and Compliance

Languages

English

Travel Availability

AS Needed

Relocation Availability

NA

Training Required

YES

Benefits

We Offer You

Receive a competitive salary and benefits package as you grow your career at Diasorin. Join our team and discover how your work can impact the lives of people all over the world.

Others Information as per Local Legal Requirements

We are an equal opportunity employer that values diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply.

EEO/AA-M/F/Disability/Protected Veteran Status/Genetic Data





Posted: 2020-01-08 Expires: 2020-02-06
Sponsored by:
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Sponsored by:
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Quality Engineer II - Cypress, United States - USA 2019-060

DiaSorin
Cypress, CA 90630

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