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    Quality Engineer II - San Diego, United States - Mastech

    Mastech
    Mastech San Diego, United States

    3 weeks ago

    Default job background
    Description
    Mastech Digital is an IT Staffing and Digital Transformation Services company.
    Mastech Digital

    provides digital and mainstream technology staff as well as Digital Transformation Services for all American Corporations. We are currently seeking a

    Quality Engineer II

    for our client in the

    Retail

    domain. We value our professionals, providing comprehensive benefits and the opportunity for growth. This is a

    Contract

    position, and the client is looking for someone to start immediately.

    Duration:

    6+ Months Contract

    Salary:
    $60.00/Hourly on W2

    Role:
    Quality Engineer II


    Primary Skills:
    Quality Assurance


    Role Description:
    The

    Quality Engineer II

    must have at least 5+ years of experience.

    The Quality Engineer II is responsible for validation of analytical methods, cleaning, production process, equipment qualification, facilities/utilities qualification, and raw materials qualification.

    Additionally, generate and maintain process FMEA for production processes, perform risk assessments for process related non-conformances and planned deviations, provide support and content for regulatory submissions, write master validation plans, protocols and reports, support equipment and facilities change controls, and perform validation impact assessment for change orders.


    Top 3 Skills:

    • Must be able to write validations
    • Someone who is organized. Very fast paced company. Will have more than one project at a time. Need to be able to multitask, go to multiple meetings, and keep to projecttimelines.

    Responsibilities:


    You may be asked to perform other function-related activities in addition to the responsibilities below as reasonably required by business needs.


    • Author master validation plans and reports.
    • Author and execute validation protocols and reports (Analytical Methods, Equipment, Facilities/Utilities, Raw Materials, Process, and Cleaning).
    • Review the quality, validation impact, and completeness of document change order requests and change controls (Equipment or Facilities).
    • Determine validation strategy based on acceptable riskbased approach.
    • Lead crossfunctional team to write PFMEAs under limited supervision.
    • Perform process risk assessment for Non-Conformance Events (NCEs) and planned deviations (PDV).
    • Support crossfunctional teams during New Product Introduction (NPI) and Sustaining projects.
    • Review regulatory submissions and/or notifications under limited supervision.
    • Propose improvement projects with supporting data, flowcharts, etc.
    • Assist in developing/updating departmental procedures and other controlled documents.
    • Evaluate adequacy of specifications for new or modified process designs under limited supervision.
    • Lead department and crossdepartment projects under limited supervision. Determine QE deliverables and assist in generating project timelines.
    • Assist QE management in Material Review Board (MRB) and Production Response Team (PRT) meetings.
    • Participate in department process improvement goal(s).
    • Assist in development, maintenance, and reporting of department metrics.
    • Provides management with status updates on assigned responsibilities, goals and escalate issues in a timely fashion.

    Note:

    • Oligonucleotide experience would be good to have
    • Typical day/daily tasks: Assessing changes to documents
    • Assessing non conformances
    • Writing protocol/report

    Education:
    Bachelor's degree in Computer Science, Electrical/Electronic Engineering, Information Technology or another related field or Equivalent

    Experience:
    Minimum 5+ years of experience

    Relocation:
    This position will not cover relocation expenses

    Travel:
    No

    Local Preferred:
    Yes

    Note:
    Must be able to work on a W2 basis (No C2C)

    Mastech Digital provides IT associates in digital and mainstream technologies, Digital Transformation Services around and SAP HANA, as well as Digital Learning Services.

    Mastech is listed on the NYSE under the symbol MHH.

    CORPORATE HEADQUARTERS
    1305 Cherrington Parkway
    Building 210, Suite 400
    Moon Township, PA 15108

    Toll-free:


    Phone:

    Fax:
    #J-18808-Ljbffr
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