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    Senior Quality Assurance Engineer - San Jose, United States - ESR Healthcare

    ESR Healthcare
    ESR Healthcare San Jose, United States

    1 week ago

    Default job background
    Description
    Senior Quality Assurance Engineer - Medical Device San Jose, CA ref


    Skills:
    Quality Assurance, Engineering, Medical Device,

    • Experience with FDA Quality System Regulations and ISO Standards (ISO 13485 and ISO is required,
    • Experience with non-conformances, CAPA, and Risk Management,
    • Experience in performing test method validation and Gage R&Rs;,
    • Extensive experience regarding root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes)
    Job description Job insights Screening questions Candidate pipeline
    Direct hire
    Your referral reward 10%
    of base salary

    Estimate:
    $15,050

    Guarantee period: 60 days

    Senior Quality Engineer - cGMP
    Over 3 months agoSan Jose, CA
    Rani Therapeutics

    Skills:
    Pharmaceutical or Biopharmaceutical experience, cGMP, Qualification activities, VHP,

    • Experience with FDA Regulations (21 CFR part 820, part 210 and part 211) and ISO Standards (ISO 13485 and ISO 14971
    Job description Job insights Screening questions Candidate pipeline
    If you post this job on a job board, please do not use company name or salary.

    Experience level:
    Mid Level (5-8 yrs exp.)

    Experience required: 7 Years Education level: Bachelor's degree Job function:

    Engineering Industry:

    Biotechnology Compensation:
    View salary Total position: 1 Relocation assistance: Yes Visa : US citizens, Greencard holders preferred
    The Sr.

    Quality Assurance Engineer supports compliance with applicable regulatory requirements by maintaining an effective quality management system and implementing continuous improvements.

    This position is responsible for activities ranging from product development through commercialization. This is a hands-on role where the Sr. Quality Engineer will apply diversified knowledge of engineering, quality principles and practices for pharmaceutical and combination products. This position requires technical expertise in Aseptic Techniques.

    The Senior Quality Engineer is responsible for performing a quality role for the aseptic manufacturing, quality systems and compliance in accordance with cGMP, related company SOP's, federal laws, guidelines, and regulations during the receipt, storage, manufacture, and distribution of products.

    Requirements

    Maintain and improve Rani Quality System in accordance with FDA Regulations and ISO 13485 requirements
    Provide hands-on direction for aseptic process and cGMP manufacturing activities
    Support quality assurance activities, including, but not limited to: Risk Management (FMEAs, HA), internal and external audits, NCMRs and CAPAs
    Collaborate with cross functional teams Manufacturing, Engineering, Facilities to ensure adherence to cGMP guidelines
    Conduct investigations for issues associated with audits, lot history records and complaints. Approve manufacturing and testing deviations and investigations
    Evaluation and support for implementation of new processes, lead continuous improvement of aseptic / sterile processes
    Lead and support qualification and validation of cGMP equipment, facilities, utility systems, analytical test methods, cleaning and manufacturing processes.

    These duties will include, but are not limited to:
    the implementation and documentation of these validations and their lifecycle management in compliance with FDA and EU regulations
    Manage the deviation system, perform QA assessment of deviations and ensure that all assessments are completed, review and approve deviation reports
    Assist in the review and approval of lot history records and test records
    Conduct audits at CMO, testing operations and internal audits
    Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ), summary reports, ensure qualifications are conducted in accordance with the Validation Master Plan
    Investigate product quality problems and determine root cause, gather and analyze data, and implement corrective actions to reduce or eliminate cause
    Lead the resolution of quality issues related to non-conformance reports and CAPAs
    Develop and initiate sampling procedures and statistical process control methods
    Address systemic quality issues with suppliers or internal groups
    Evaluate product changes for qualification and validation requirements and assist in change implementations
    Other duties/ activities may be necessary to support departmental or company goals
    Education and Job Experience

    Bachelor's degree or higher in Chemistry, Biology, or equivalent scientific discipline
    A minimum of 7 years quality assurance/engineering experience within the pharmaceutical or biopharmaceutical industry is required
    cGMP experience is required
    Experience with performing utility qualification activities for vaporized hydrogen peroxide (VHP) system is preferred Excellent communication skills both oral and written
    Understands and applies comprehensive knowledge of quality and GMP principles. Maintains current understanding of global GMP regulations
    Experience with FDA Regulations (21 CFR part 820, part 210 and part 211) and ISO Standards (ISO 13485 and ISO is required
    Experience regarding root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes)
    Skills and Specifications

    Ability to motivate and influence people
    Must possess the ability to handle multiple tasks with high attention to detail Organizing, planning, and problem-solving skills
    Good interpersonal and communication skills
    Ability to work as a part of a team
    Ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports
    Ability to create and provide training
    Good statistical and numerical ability

    #J-18808-Ljbffr
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