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    Principal Quality Engineer - Irvine, United States - Meet

    Meet
    Meet Irvine, United States

    Found in: Appcast US C2 - 5 hours ago

    Default job background
    Upper Management / Consulting
    Description

    Primary Job Responsibilities / Skills

    • Lead quality engineering initiatives to meet organizational goals.
    • Offer guidance and direction in the formulation and assessment of validation policies, schedules, and protocols, as well as quality engineering matters. Demonstrate effective leadership or collaboration within quality-related decisions and practices.
    • Assist in enhancing process quality and testing procedures within the engineering department.
    • Provide technical proficiency in risk documentation processes.
    • Lead or participate in investigations concerning manufacturing non-conformities, product/component failures, customer complaints, or product returns. Conduct technical troubleshooting, FMEA, hazard analysis, root cause determination, and recommend CAPA solutions.
    • Contribute to non-conformance investigations, responses, and corrective action plans as necessary.
    • Provide direction and expertise in statistical methodologies, risk analyses, and other quality engineering tools.
    • Support supplier qualification efforts and collaborate with relevant departments on SCRs.
    • Lead design process characterization studies (DOE, R&R); analyze results statistically to identify critical parameters and enhance process capability.
    • Participate in Design Control New Product development teams. Offer guidance on design control requirements and review and approve related quality engineering and validation deliverables.
    • Perform other duties as assigned.

    Requirements

    Education & Training:

    • Bachelor's degree in Engineering or related sciences preferred.
    • Advanced degree is advantageous.
    • Certified Quality Engineer (CQE) or equivalent certification preferred.

    Experience:

    • Minimum of five years' experience in validation and/or quality engineering within the medical device industry, including practical application of FDA Quality System Regulation and ISO 13485, or equivalent combination of education/experience.
    • Prior experience with class II or III medical devices
    • Understanding of manufacturing processes such as injection molding, assembly, packaging, and sterilization is essential.
    • Knowledge of international/ISO standards in ophthalmology is advantageous.
    • Familiarity with regulatory/compliance/validation matters is required. Candidates should be self-motivated, intelligent, and dependable.

    Skills:

    • Excellent project management, organization, writing, communication, and presentation skills are essential.
    • Ability to communicate effectively across various styles and influence consensus among cross-functional groups.
    • Proficiency in technical writing, especially compliance and/or Validation/quality assurance documents and protocols, is necessary.
    • Familiarity with basic quality tools for formatting, trending, and presenting information (e.g., scatter plots, histograms, Pareto diagrams, flow charts, SPC, FMEA, Fault Tree Analysis) is required.
    • Proficiency in compiling, analyzing, graphing, and comparing data using standard statistical techniques (e.g., t-tests, ANOVA, linear regression analysis) is essential.
    • Demonstrated expertise in Windows-based software, including Word, Excel, Access, Project, and PowerPoint.
    • Proficiency in written and spoken English is required.
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