Quality Assurance Specialist

6 days ago

Durham, North Carolina, United States AISIN North Carolina Corporation Full time
About the Role

AISIN North Carolina Corporation is seeking a highly skilled Quality Engineer to join our Plant Quality Team. As a Quality Engineer, you will play a critical role in ensuring the quality of our products and processes.

Key Responsibilities
  • Quality Engineering Support: Provide statistical information and accurate reporting to promote quality improvement across all manufacturing processes, equipment, and products.
  • Process Improvement: Review current systems and standards by utilizing quality tools to assess and continuously improve processes.
  • Quality Concerns: Respond to any quality concerns regarding procedures and/or end products by employing problem-solving techniques and root cause analyses.
  • Supplier and Customer Interaction: Interact with suppliers and customers at a technical level to have a clear understanding of the needs and concerns of both our company and those with whom we deal.
Job Functions
  • Customer Requirements: Ensure customer requirements (internal & external) are met or exceeded in the manufacturing environment.
  • Technical Discussions: Lead technical discussions with internal customers.
  • Audits and Compliance: Perform audits to ensure adherence to company policies, procedures, and customer requirements.
  • Data Analysis and Reporting: Organize and present data to management for decision-making, including creating reports via Microsoft Office.
  • Problem-Solving Efforts: Lead teams in structured problem-solving efforts to improve products via internal manufacturing processes and/or external materials.
Basic Qualifications
  • Education and Experience: BS Engineering and 1-3+ years' work experience in an engineering role or equivalent experience.
  • Quality Tools and Knowledge: Ability to explain quality tools such as statistics, inspection methods, and GD&T, demonstrated ability to review and interpret GD&T standards.
  • Problem-Solving Techniques: Understand problem-solving techniques such as 5Y, 8D, and root cause analysis.
  • Communication Skills: Good verbal and written communication skills.
  • Analytical and Technical Skills: Be able to analyze information, develop standards, manage processes, and promote process improvement.
  • Software Skills: Microsoft Office (Word, Excel, PowerPoint).
Preferred Qualifications
  • Quality Assurance Experience: 5 years of experience in a Quality Assurance capacity.
  • Automotive and Mechanical Knowledge: Basic automotive and mechanical knowledge.
  • Transmission Function Evaluation: Automatic Transmission Function Evaluation or Product Design/Manufacture experience.
  • Tier One Automotive Manufacturing: Experience in a Tier One automotive manufacturing facility.
  • Product Design: Product Design experience (functional, and finished part).

  • Quality Assurance Specialist

    5 days ago

    Durham, North Carolina, United States Lilly Full time

    Job Title: Quality Assurance SpecialistWe're seeking a highly skilled Quality Assurance Specialist to join our team at Lilly. As a key member of our Quality Assurance team, you will play a critical role in ensuring the quality and safety of our products.Job Summary:The Quality Assurance Specialist will be responsible for reviewing batch records, performing...

  • Quality Assurance Specialist

    2 weeks ago

    Durham, North Carolina, United States Carolina Components Group Full time

    Job SummaryJob Title: Quality Assurance SpecialistJob Type: Full-timeLocation: Durham, NCJob Summary: The Quality Assurance Specialist is responsible for ensuring process, material, and assembly compliance to customer specifications, regulatory requirements, and company standards. The individual is responsible for understanding and effectively operating...

  • Quality Assurance Specialist

    6 days ago

    Durham, North Carolina, United States AISIN North Carolina Corporation Full time

    About the RoleAISIN North Carolina Corporation is seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our Supply Chain Quality team, you will be responsible for ensuring the quality of supplied parts and materials.Key ResponsibilitiesQuality Control and Assurance: Conduct regular audits and inspections to ensure...

  • Senior Quality Assurance Specialist

    4 days ago

    Durham, North Carolina, United States Humacyte Global, Inc. Full time

    Senior Quality Assurance SpecialistHumacyte Global, Inc. is a leading biotechnology company developing innovative solutions for tissue repair and replacement. We are seeking a highly skilled Senior Quality Assurance Specialist to join our Quality Assurance Team.Key Responsibilities:Design and implement comprehensive Product Technical Complaints (PTC) and...

  • Quality Assurance Inspection Specialist

    3 weeks ago

    Durham, North Carolina, United States Eli Lilly Full time

    Position OverviewThe Quality Assurance Inspection Specialist will play a crucial role during the project phase by facilitating the commissioning and qualification processes necessary for the operational readiness of inspection lines. This position involves the use of both semi-automated and automated technologies to ensure optimal functionality.Key...

  • Software Quality Assurance Specialist

    3 weeks ago

    Durham, North Carolina, United States AICPA Full time

    Software Quality Assurance SpecialistAICPADurham, North CarolinaA highly driven and skilled professional responsible for overseeing, executing, and enhancing the overall quality assurance (QA) results through meticulous planning, control, and execution of testing to support various methodologies including Agile, Scrum, Waterfall, and Hybrid processes. This...

  • Manufacturing Quality Assurance Specialist

    2 weeks ago

    Durham, North Carolina, United States Fujifilm Corporation Full time

    About the RoleFujifilm Diosynth Biotechnologies is a leading Contract Development and Manufacturing Organization (CDMO) that partners with clients to deliver innovative solutions for the biopharmaceutical industry. We are seeking a highly motivated Senior QA Technical Specialist to join our team in Research Triangle Park, NC.Key ResponsibilitiesFunction as...

  • Quality Assurance Operations Specialist

    7 days ago

    Durham, North Carolina, United States CARsgen Therapeutics Full time

    Job SummaryThe Quality Assurance Operations Specialist will be responsible for day-to-day support of Good Manufacturing Practice (GMP) operations at CARsgen Therapeutics' facility for clinical and commercial products.Key ResponsibilitiesQA Operations Support: Provide on-the-floor QA support for GMP operations, including in-process batch record review, QA...

  • Quality Assurance Specialist III

    2 weeks ago

    Durham, North Carolina, United States HUMACYTE GLOBAL INC Full time

    Job SummaryThe Quality Assurance Specialist III provides critical support to the overall Quality Assurance program at Humacyte Global Inc. Ensuring manufacturing operations are in compliance with cGMP and GTP regulations and local procedures is a key responsibility.Key ResponsibilitiesLead and provide oversight to operations on the shop floor, supporting...

  • Senior Quality Assurance Specialist

    4 days ago

    Durham, North Carolina, United States KBI BioPharma Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at KBI Biopharma. The successful candidate will be responsible for ensuring the quality and compliance of our products, collaborating with cross-functional teams, and mentoring junior QA staff.Key ResponsibilitiesCollaborate with Manufacturing, QA, and other departments...

  • Cell & Gene Therapy Quality Assurance Analyst

    2 weeks ago

    Durham, North Carolina, United States Piper Companies Full time

    Piper Companies is currently in search of a Quality Assurance Specialist to become part of a cell and gene therapy organization focused on developing groundbreaking AAV platform products aimed at addressing complex diseases. The Quality Assurance Specialist will play a crucial role in the evaluation and endorsement of data within a GMP framework. This...

  • Quality Assurance Specialist

    5 days ago

    Durham, North Carolina, United States BioSpace, Inc. Full time

    About the OpportunityWe are seeking a highly motivated and detail-oriented Quality Assurance Intern to join our team at Novo Nordisk. As a Quality Assurance Intern, you will have the opportunity to gain hands-on experience in quality management processes, with a focus on document control and records management.Key ResponsibilitiesConduct research, gather,...

  • Senior Auditor for Quality Assurance

    3 days ago

    Durham, North Carolina, United States Proclinical Staffing Full time

    Senior Auditor for Quality AssuranceProclinical Staffing is currently recruiting for a dedicated Senior Auditor for Quality Assurance to join a CRO. This role focuses on maintaining and enhancing quality initiatives within the company, including SOPs and training, computer systems validation, and Quality Management System.Key Responsibilities:Maintain the...

  • Senior Auditor for Quality Assurance

    3 days ago

    Durham, North Carolina, United States Proclinical Staffing Full time

    Senior Auditor for Quality AssuranceProclinical Staffing is seeking a dedicated Senior Auditor for Quality Assurance to join a CRO. This role focuses on maintaining and enhancing quality initiatives within the company, including SOPs and training, computer systems validation, and Quality Management System.Key Responsibilities:Maintain the Quality Management...

  • Quality Assurance Technical Lead

    2 weeks ago

    Durham, North Carolina, United States Fujifilm Corporation Full time

    About the RoleFujifilm Diosynth Biotechnologies is a leading Contract Development and Manufacturing Organization (CDMO) that partners with clients to deliver innovative solutions for the biopharmaceutical industry. We are seeking a highly motivated Senior QA Technical Specialist to join our team in Research Triangle Park, NC.Key ResponsibilitiesFunction as...

  • Lead Quality Assurance Expert

    2 weeks ago

    Durham, North Carolina, United States HUMACYTE GLOBAL INC Full time

    Job OverviewPosition Title: Senior Quality Assurance SpecialistCompany Overview:Humacyte, Inc. is pioneering a groundbreaking scientific technology platform, focusing on bioengineering innovative and universally applicable product solutions aimed at enhancing patient outcomes and revolutionizing medical practices. The organization is engaged in the...

  • Validation Specialist

    2 weeks ago

    Durham, North Carolina, United States Verista Full time

    About VeristaVerista is a leading provider of innovative solutions and services to the life science industry. Our team of experts works closely with top brands to empower growth and innovation within the scientific community.Job SummaryWe are seeking a highly skilled Validation Engineer - Quality Assurance Specialist to join our team. As a key member of our...

  • Quality Assurance Specialist

    2 weeks ago

    Durham, North Carolina, United States AISIN North Carolina Corporation Full time

    Job Summary:The Supplier Quality Engineer will play a crucial role in ensuring the quality of supplied parts and manufacturing processes at AISIN North Carolina Corporation. This position will be responsible for investigating quality problems, providing statistical information, and promoting quality improvement activities.The successful candidate will travel...

  • Specialist, Quality Assurance

    2 months ago

    Durham, North Carolina, United States Merck Full time

    Job DescriptionOur company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its legacy for over a century. Our success is backed...

  • Director of Quality Assurance

    6 days ago

    Durham, North Carolina, United States BiotechPharma Full time

    Job DescriptionJob Title: Director of Quality AssuranceJob Summary:We are seeking a highly experienced and skilled Director of Quality Assurance to join our team. The successful candidate will be responsible for leading our Quality Assurance function, ensuring that all aspects of quality are met and exceeded.Key Responsibilities:Lead the Quality Assurance...