Quality Assurance Associate II

2 weeks ago


Irvine, California, United States Seegene USA Full time
Job Title: Quality Assurance Associate II

Seegene USA, Inc. is a global leader in molecular diagnostics, dedicated to advancing science and developing innovative technologies. We are seeking a highly motivated and detail-oriented Quality Assurance Associate II to join our team.

Job Summary:

The Quality Assurance Associate II will play a critical role in ensuring the quality of our products and services. This includes assisting in the development and implementation of quality policies and procedures, maintaining records and revision control, and participating in audits and investigations.

Key Responsibilities:
  • Assist in the improvement of SOPs, work instructions, policies, procedures, job aids, and business process communications
  • Participate in documenting reports for tracking and trending of events
  • Maintain records and revision control in the SGUS electronic Quality Management System (eQMS)
  • Participate in evaluation of customer complaints, initiation of CAPA Investigations, tracking and trending of events
  • Aid in maintaining training and safety documentation for employee records and audits
  • Perform Verifications, Inspections, and maintaining equipment records and certifications
  • Learn the use of process mapping techniques, lean, or Six Sigma process improvement methodology to reduce waste
  • Participate in corrective action investigations, process improvement teams, audits, customer visits and strategy discussions
  • Contribute to Supply chain audits, client audits, and internal process audits with the Quality Manager
  • Assist in documenting minutes for audit report write-ups
Requirements:
  • Bachelor's degree in engineering or science related fields
  • 2 years prior experience in Quality Assurance or Quality related field
  • Must be familiar with Quality Standards. Experience with Good Manufacturing Practices (GMP), FDA Quality Systems Requirements (21 CFR Part 820), and ISO standards (i.e. ISO 13485)
  • Demonstrated experience working with contract manufacturers, suppliers, or distributors
  • Proficiency in Microsoft Office
  • Experience in quality management systems
Preferred Qualifications:
  • Experience with Diagnostic Labs, Life Science, Biopharma or related business
  • Understanding of GMP regulations
  • Experience with eQMS (such as Master Control, Greenlight Guru, Veeva, TrackWise, etc.)

Seegene USA, Inc. is an equal opportunity employer. We are committed to creating a diverse and inclusive work environment that values and respects all employees. We do not discriminate against employees or applicants on any legally protected basis, including, but not limited to, race, color, religion, gender, gender identity, marital status, sexual orientation, national origin, ancestry, veteran's status, age, or disability which does not interfere with an individual's ability to perform the essential functions of his or her job position with or without reasonable accommodation.



  • Irvine, California, United States Seegene USA Full time

    Job Title: Quality Assurance Associate IISeegene USA, Inc. is a global leader in molecular diagnostics, dedicated to advancing science and developing innovative technologies. We are seeking a highly motivated and detail-oriented Quality Assurance Associate II to join our team.Job Summary:The Quality Assurance Associate II will play a critical role in...


  • Irvine, California, United States Seegene USA Full time

    {"title": "Quality Assurance Associate II", "description": "Job SummarySeegene USA, Inc. is a global leader in molecular diagnostics, and we are seeking a highly skilled Quality Assurance Associate II to join our team. As a Quality Assurance Associate II, you will play a critical role in ensuring the quality of our products and services, and contributing to...


  • Irvine, California, United States Seegene USA Full time

    Job Title: Quality Assurance Associate IISeegene USA, Inc. is a global leader in molecular diagnostics, dedicated to advancing science and developing innovative technologies. We are seeking a highly motivated and detail-oriented Quality Assurance Associate II to join our team.Job Summary:The Quality Assurance Associate II will play a critical role in...


  • Irvine, California, United States Masimo Full time

    Job SummaryThe Product Assurance and Reliability Engineer II position at Masimo is a multifaceted role that requires a strong understanding of basic science and engineering principles. As a member of the Product Assurance department, you will investigate, test, and provide expertise to improve the quality and reliability of Masimo's product portfolio.Key...


  • Irvine, California, United States Taco Bell Full time

    About the RoleWe are seeking a highly skilled Associate Manager, Quality Engineering to join our team at Taco Bell. As a key member of our quality assurance team, you will be responsible for ensuring the highest quality of our APIs and integrations.Key ResponsibilitiesDevelop and execute test plans, test cases, and automation scripts to ensure thorough...

  • Quality Inspector II

    3 weeks ago


    Irvine, California, United States First Tek Full time

    Job Title: Quality Inspector IIFirst Tek is seeking a highly skilled Quality Inspector II to join our team. As a Quality Inspector II, you will be responsible for performing visual and mechanical inspections of electronic and electromechanical assemblies and subassemblies.Key Responsibilities:Perform visual/mechanical inspections of electronic and...


  • Irvine, California, United States PRISMATIK DENTALCRAFT, INC. Full time

    About the RoleAt Prismatik Dentalcraft, Inc., we are seeking a highly skilled Quality Assurance Engineering Manager to join our team. As a key member of our organization, you will play a critical role in ensuring the quality and compliance of our products.Key ResponsibilitiesQuality Management: Develop and implement quality management systems to ensure...


  • Irvine, California, United States SysMind Tech Full time

    Job Title: Quality Assurance SpecialistJoin SysMind Tech as a Quality Assurance Specialist and take on a challenging role that requires strong analytical and problem-solving skills. As a key member of our team, you will be responsible for ensuring the quality of our products and services, while also driving process improvements and compliance with regulatory...


  • Irvine, California, United States Compunnel Inc. Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Compunnel Inc. as a Quality Engineer. The successful candidate will be responsible for ensuring the quality of our products and processes, and will play a key role in maintaining our company's reputation for excellence.Key ResponsibilitiesInvestigate and Resolve...


  • Irvine, California, United States Parker Hannifin Corporation Parker Aerospace Group Full time

    Job SummaryThe Quality Inspector III plays a critical role in ensuring the quality and reliability of complex components, parts, and products. This position requires a high level of expertise in quality assurance and the ability to work independently with minimal supervision.Key ResponsibilitiesConduct complex examinations and quality control inspections on...


  • Irvine, California, United States Parker Hannifin Corporation Full time

    Job SummaryThe Quality Inspector III plays a crucial role in ensuring the quality and reliability of complex components, parts, and products. This position requires a high level of expertise in quality assurance and the ability to work independently with minimal supervision.Key ResponsibilitiesConduct complex examinations and quality control inspections on...


  • Irvine, California, United States Kaygen Inc. Full time

    Job SummaryKaygen Inc. is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and services. This is a challenging and rewarding role that requires strong analytical and problem-solving skills.Key ResponsibilitiesConduct quality checks on...


  • Irvine, California, United States JobsRUs Full time

    Job Title: Quality EngineerJobsRUs is seeking a highly skilled Quality Engineer to join our team in Irvine, CA. As a Quality Engineer, you will play a critical role in ensuring the quality of our products and processes.Key Responsibilities:Develop and implement quality standards and evaluation methods for products and processesProvide statistical information...


  • Irvine, California, United States hireVouch Full time

    About the RoleWe are seeking a skilled Quality Assurance Specialist to join our team at hireVouch. As a QA Specialist, you will play a critical role in ensuring the quality and reliability of our software products.Key ResponsibilitiesDesign and execute comprehensive testing strategies to identify and report defects in our software applications.Collaborate...


  • Irvine, California, United States EBizCharge Full time

    Quality Assurance EngineerAt EBizCharge, we're seeking a skilled Quality Assurance Engineer to join our team. As a key member of our software development team, you'll play a critical role in ensuring the highest level of quality control for our integrated payment solutions.Responsibilities:Develop and implement test plans, test cases, and test scripts for...


  • Irvine, California, United States Ultimate Staffing Full time

    Job DescriptionJob Summary:Ultimate Staffing is seeking a highly skilled Quality Assurance Engineer to join our team. As a Quality Assurance Engineer, you will be responsible for investigating and resolving quality issues in our manufacturing processes.Key Responsibilities:Investigate and analyze quality issues in manufacturing processes to identify root...


  • Irvine, California, United States Cenergy International Full time

    Job Title: Quality Assurance SpecialistCenergy International is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for performing visual and mechanical inspections of electronic and electromechanical assemblies and subassemblies.Key Responsibilities:Perform visual/mechanical...


  • Irvine, California, United States ShiftCode Analytics Full time

    Job Title: Senior Quality Assurance EngineerJoin ShiftCode Analytics as a Senior Quality Assurance Engineer and play a key role in ensuring the quality of our products. As a member of our quality team, you will be responsible for designing and implementing quality assurance processes, collaborating with cross-functional teams, and ensuring compliance with...


  • Irvine, California, United States MGO Full time

    Job SummaryWe are seeking a highly skilled and experienced Senior Assurance Associate to join our team at MGO. As a key member of our assurance team, you will be responsible for leading and managing engagements, providing guidance to junior team members, and ensuring the delivery of high-quality services to our clients.Key ResponsibilitiesLead and manage...


  • Irvine, California, United States IRVINEi Full time

    Quality Assurance EngineerWe are seeking a skilled Quality Assurance Engineer to play a vital role in ensuring the quality and performance of our mobile applications.Key Responsibilities:Develop comprehensive test cases to thoroughly evaluate new features.Create detailed test plans to guide the testing process.Execute smoke, sanity, and regression testing to...