Talent.com
Quality Engineer
Quality EngineerMastech Digital • San Diego, CA, United States
Quality Engineer

Quality Engineer

Mastech Digital • San Diego, CA, United States
job_description.job_card.variable_hours_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

Job Summary

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.

Essential Duties and Responsibilities

  • Provides Quality leadership to new product development teams in the areas of validation, design transfer, risk management and specification development.
  • 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 risk-based approach.
  • Lead cross-functional team to write PFMEAs under limited supervision.
  • Perform process risk assessment for Non-Conformance Events (NCEs) and planned deviations (PDV).
  • Assist in maintaining validation records.
  • Support cross-functional 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 cross-department projects under limited supervision. Determine QE deliverables and assist in generating project timelines.
  • Participate in process design reviews.
  • Assist QE management in Material Review Board (MRB) and Production Response Team (PRT) meetings.

Qualifications

Education

  • Bachelor’s degree in Science or Engineering.
  • Experience

  • 2 years of experience in a diagnostic, medical device, biotech or pharmaceutical company .
  • Skills

  • Proficient in validation methods and evaluation criteria .
  • Experience with process validation, analytical method validation, cleaning validation, facility / utility and equipment qualifications .
  • Experience with change control process and documentation requirements .
  • Experience with electronic document management systems.
  • Understanding of statistics, SPC and acceptance sampling.
  • Experience with risk analysis and PFMEA.
  • Working knowledge of CDRH, CBER and ISO regulations (e.g., 21 CFR Part 820, ISO 13485, ISO 14971).
  • Working knowledge of 21 CFR Part 11.
  • serp_jobs.job_alerts.create_a_job

    Quality Engineer • San Diego, CA, United States

    Job_description.internal_linking.related_jobs
    Quality Engineer

    Quality Engineer

    QuidelOrtho • Carlsbad, CA, United States
    serp_jobs.job_card.full_time
    QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecula...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Senior Product Quality Engineer

    Senior Product Quality Engineer

    VirtualVocations • Escondido, California, United States
    serp_jobs.job_card.full_time
    Key Responsibilities Lead and support the completion of Design Control deliverables Support Design Verification and Validation planning and execution Lead Risk Management activities from produc...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Senior Quality Engineer

    Senior Quality Engineer

    Bolt Medical • Carlsbad, CA, United States
    serp_jobs.job_card.full_time
    DIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST.The Senior Quality Engineer will be responsible for providing quality engineering support and leadership for Manufacturing Process devel...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Quality Engineer

    Quality Engineer

    VirtualVocations • El Cajon, California, United States
    serp_jobs.job_card.full_time
    A company is looking for a Quality Engineer located in Memphis, TN.Key Responsibilities Design, develop, and sustain quality processes and inspection methods, including procedures and documentati...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Quality Automation Engineer

    Quality Automation Engineer

    VirtualVocations • Escondido, California, United States
    serp_jobs.job_card.full_time
    A company is looking for a Quality Automation Engineer to join their ERP development team remotely.Key Responsibilities Design and develop the test automation framework and supporting infrastruct...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Quality Engineer II

    Quality Engineer II

    Manpower San Diego • San Diego, CA, United States
    serp_jobs.job_card.full_time
    The Quality Engineer II is responsible for validation of analytical methods, cleaning, production process, equipment qualification, facilities / utilities qualification, and raw materials qualificati...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
    Senior Quality Assurance Engineer

    Senior Quality Assurance Engineer

    VirtualVocations • Escondido, California, United States
    serp_jobs.job_card.full_time
    A company is looking for a Senior Quality Assurance Engineer.Key Responsibilities Design, develop, and execute comprehensive test strategies for various applications Collaborate with cross-funct...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Design Quality Engineer

    Design Quality Engineer

    Enovis • Carlsbad, CA, United States
    serp_jobs.job_card.full_time
    Enovis Corporation (NYSE : ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcome...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    QA Engineer II

    QA Engineer II

    VirtualVocations • Escondido, California, United States
    serp_jobs.job_card.full_time
    A company is looking for a QA Engineer II (with SEO Testing Experience).Key Responsibilities Assist in developing and implementing comprehensive test plans and strategies Execute test cases usin...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Customer Quality Engineer

    Customer Quality Engineer

    VirtualVocations • Escondido, California, United States
    serp_jobs.job_card.full_time
    A company is looking for a Customer Quality Engineer to ensure customer quality and reliability requirements are met while addressing any quality issues. Key Responsibilities Review customer quali...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
    Quality Engineer (Carlsbad)

    Quality Engineer (Carlsbad)

    BioTalent • Carlsbad, CA, US
    serp_jobs.job_card.part_time
    NO C2C OR THIRD PARTIES • • • • • • • • • • • • • • • • • • • • • • •.Join an innovative medical-device team focused on improving patient outcomes through engineering excellence and regulatory precision.Develop and maint...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Design Quality Engineer

    Design Quality Engineer

    EPM Scientific • San Diego, CA, United States
    serp_jobs.job_card.full_time
    We are seeking an experienced quality professional to join our team and support critical product development activities.This role focuses on ensuring that design processes meet internal standards a...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
    Mid-Level Quality Engineer

    Mid-Level Quality Engineer

    VirtualVocations • El Cajon, California, United States
    serp_jobs.job_card.full_time
    A company is looking for a Mid-Level Quality Engineer to enhance internal applications and ensure system performance.Key Responsibilities Troubleshoot and resolve issues through root cause analys...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Certification Engineer

    Certification Engineer

    VirtualVocations • Escondido, California, United States
    serp_jobs.job_card.full_time
    A company is looking for a Certification Engineer to join their integration team.Key Responsibilities : Develop technical design documentation for complex interfaces Certify new vendor systems an...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Senior QA Engineer

    Senior QA Engineer

    VirtualVocations • Escondido, California, United States
    serp_jobs.job_card.full_time
    A company is looking for a Senior QA Engineer - Remote.Key Responsibilities Develop and implement comprehensive test strategies for client applications Collaborate with stakeholders to identify ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Automation Quality Engineer

    Automation Quality Engineer

    VirtualVocations • Chula Vista, California, United States
    serp_jobs.job_card.full_time
    A company is looking for an Automation Quality Engineer to ensure the reliability and excellence of their cloud-native healthcare platform. Key Responsibilities Build and maintain UI, API, and bac...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
    Senior Quality Engineer - CONTRACT POSITION

    Senior Quality Engineer - CONTRACT POSITION

    BioTalent • Carlsbad, CA, United States
    serp_jobs.job_card.full_time
    NO C2C OR THIRD PARTIES • • • • • • • • • • • • • • • • • • • • • • •.Join an innovative medical-device team focused on improving patient outcomes through engineering excellence and regulatory precision.Quality Engineer / ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Quality Assurance Engineer

    Quality Assurance Engineer

    VirtualVocations • Escondido, California, United States
    serp_jobs.job_card.full_time
    A company is looking for a QA Engineer to oversee the planning, design, development, and execution of test suites.Key Responsibilities Own the quality of features and lead test efforts for conten...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted