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Mfg/Ops Quality Engineer 2

Company: Illumina
Location: San Diego
Posted on: June 15, 2019

Job Description:

Responsibilities:

  • Provide ongoing support for QC testing and product release throughout the product life cycle
  • Work with QC group to ensure understanding of and compliance with regulations, procedures, and requirements. Provide training, guidance and interpretation as needed
  • Establish and/or improve processes for raw material and product release
  • Review and approve QC work instructions and change orders
  • Review and approve raw material and product release test data, ensuring data integrity and compliance with test procedures and release criteria
  • Balance risk, regulatory impact and business needs to achieve efficient and effective solutions for QC process improvement
  • Collaborate cross functionally to manage non-conformance reports, change orders, and deviations, ensuring evaluation is performed in a timely manner and is properly documented
  • Work with manufacturing teams to ensure understanding of and compliance with regulations, procedures, and requirements. Provide training, guidance and interpretation as needed
  • Review and approve validation protocols and reports, ensuring quality and completeness of validation packages
  • Identify gaps in GMP compliance
  • Develop and execute strategies to close gaps in an efficient and compliant manner to improve quality systems and manufacturing processes
  • Participate in non-conformance investigations and ensure CAPA findings, risks, recommendations and outcomes are appropriate and are clearly documented and communicated
  • Apply experience and knowledge of regulations and standards to manage risks and guide actions independently
  • Become familiar with the applicable technology to participate in technical discussions and risk-based decision-making
  • Trend, analyze, and report on quality data in order to improve product and process
  • Develop recommendations based on data analysis
  • Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion
  • Other such duties that may be determined by ManagementRequirements:
    • 4+ years relevant experience required
    • Experience applying quality regulations and standards (21CFR 820, ISO13485) and establishing quality systems
    • Experience in QC testing, data review, and product release
    • Experience in change control and failure investigation
    • Experience in project management
    • Applied experience with quality and statistical tools (SPC, 6 sigma, Risk Analysis, FMEA, Trend Analysis)
    • Excellent attention to detail, well organized and able to work independently and as a team
    • Excellent interpersonal, verbal and written communication skills
    • Knowledge and skills typically acquired through previous positions in fast-paced corporate environments which involved responsibility for similar workListed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you have a disability or special need that requires accommodation, please contact us at . To learn more, visit:

Keywords: Illumina, San Diego , Mfg/Ops Quality Engineer 2, Engineering , San Diego, California

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