Senior Quality Assurance Specialist

5 days ago


Durham, North Carolina, United States MILLENNIUMSOFT Full time

Job Title: Senior Quality Assurance Specialist

Estimated Salary: $70,000 - $90,000 per year

About the Job:

The Staff Quality Engineer will support the Quality team at our Durham, NC R&D facility to ensure that design history files (DHF) for identified products meet all corporate policies, government regulations, and medical device industry standards for Design Controls.

The position will primarily work with Quality Assurance to ensure comprehensive Design History Files exist for Women's Health and Cancer products maintained at the Durham, NC R&D facility.

Duties and Responsibilities:

  • Review current DHF files to identify gaps.
  • Review related documentation for addition to the DHF.
  • Create quality records/documentation to supplement the DHF, as appropriate.
  • Update DHF indices and hard copy files, as appropriate.
  • Exhibit an excellent attention to detail with a high degree of accuracy, and the ability to work independently, and in team situations.
  • Interact with other functions as needed.

Requirements:

  • Bachelor's Degree.
  • Experience in Design Control/Quality Assurance.


  • Durham, North Carolina, United States Integrated Resources, Inc Full time

    Integrated Resources, Inc. is seeking an experienced Senior Quality Assurance Specialist to join our team in Durham, NC.About the RoleThis position will be responsible for environmental monitoring in aseptic environments, collection and processing of water samples, component, and product release testing. The ideal candidate must have strong interpersonal,...


  • Durham, North Carolina, United States Baebies Inc. Full time

    Job Title:Senior Quality Assurance Engineer SpecialistJob Description:We are seeking a highly experienced and skilled Senior Quality Assurance Engineer to join our team at Baebies Inc. in the medical device industry.About the Role:The Senior Quality Assurance Engineer will be responsible for ensuring compliance with FDA, IVDD, IVDR, and ISO 13485 regulations...


  • Durham, North Carolina, United States Tempus Full time

    About the RoleTempus is seeking a Senior Supplier Quality Assurance Specialist to play an integral role in supporting quality activities related to Supplier Quality Management (SQM) in accordance with the FDA Quality System Regulation, ISO 13485, and other medical device/IVDR regulations.This individual will also support various QMS activities that comply...


  • Durham, North Carolina, United States Kikiktagruk Inupiat Corporation Full time

    Job DescriptionWe are seeking a Quality Assurance Specialist to support our federal contract in Durham, NC.The ideal candidate will have great communication skills and work well with a team, is adaptable, act in a positive, professional, and helpful manner, and demonstrate a strong work ethic.Perform necropsies, including sentinel animals, and record all...


  • Durham, North Carolina, United States PEAK Technical Staffing USA Full time

    Job DescriptionAt PEAK Technical Staffing USA, we are seeking a highly skilled Quality Assurance Specialist to join our team. This is a full-time position with a competitive salary of $16-$17/hour.The ideal candidate will have a strong attention to detail and be able to read instructions to understand quality expectations for products and raw materials.**Key...


  • Durham, North Carolina, United States MedPharm Full time

    Job Description:At MedPharm, we are seeking an experienced Quality Assurance Specialist to join our team. This is a critical role that requires expertise in validation protocols and regulatory compliance.In this position, you will be responsible for collaborating with various teams to develop, execute, and report on qualification protocols. You will ensure...


  • Durham, North Carolina, United States NavitsPartners Full time

    Job DescriptionAt NavitsPartners, we are seeking a highly skilled Quality Assurance Specialist to support our validation activities throughout the product lifecycle. As a key member of our team, you will be responsible for providing validation support for equipment calibration documentation and ensuring compliance with corporate and industry standards.The...


  • Durham, North Carolina, United States NetApp Full time

    Job Title: Distinguished Engineer, Cloud BusinessAbout the Role:We are seeking a seasoned quality assurance expert to join our team at NetApp as a Cloud Operations Quality Assurance Specialist.This is an exceptional opportunity for a professional with a passion for quality and efficiency to drive process improvements in our cloud business.Key...


  • Durham, North Carolina, United States MILLENNIUMSOFT Full time

    Job Title: Staff Quality Engineer Location: Durham, NC Duration: 9+ Months Contract Total Hours/week: 40.00 The Millenniumsoft company is seeking a highly skilled Staff Quality Engineer to support the Quality team at our Durham, NC R&D facility. The successful candidate will ensure that design history files (DHF) for identified products meet all corporate...


  • Durham, North Carolina, United States A-Line Staffing Solutions Full time

    Job OverviewA-Line Staffing Solutions is currently seeking a Quality Inspection Specialist to join their team in Durham, NC.This full-time position offers career growth potential and requires the candidate to work 40+ hours per week.About the JobThe Quality Inspection Specialist will be responsible for the efficient and effective performance of testing in...


  • Durham, North Carolina, United States TalentBurst Full time

    We are seeking a highly detail-oriented Production Quality Assurance Specialist to join our team at TalentBurst in Durham, NC. As a key member of our production team, you will be responsible for ensuring the quality and integrity of our products from start to finish.About the RoleThe ideal candidate will have at least 1 year of experience within a...


  • Durham, North Carolina, United States NetApp Full time

    We are seeking a skilled Software Quality Assurance Engineer to join our team at NetApp.Company OverviewNetApp is a leader in data management solutions, helping customers turn challenges into business opportunities. Our innovative approach combines fresh thinking with proven expertise to deliver exceptional results.Job SummaryThis role involves working...


  • Durham, North Carolina, United States KBI BioPharma Full time

    About UsKBI BioPharma is a leading biopharmaceutical company that strives to deliver high-quality products and services.Job DescriptionWe are seeking an experienced Deviation Specialist to join our team. The successful candidate will be responsible for ensuring the timely review and approval of Deviations, CAPAs and ECs, in accordance with cGMP requirements...


  • Durham, North Carolina, United States Aspida Financial Services LLC Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Actuary to join our team at Aspida Financial Services LLC. As a key member of our actuarial department, you will play a critical role in ensuring the accuracy and quality of our annuity products.**Responsibilities:**Develop and maintain annuity product calculation engines to ensure precision and...


  • Durham, North Carolina, United States SBM Management Services Full time

    Job OverviewSBM Management Services, LP is a leading provider of management solutions. We are seeking a highly skilled Quality Assurance Manager to join our team.


  • Durham, North Carolina, United States Fidelity TalentSource LLC Full time

    Job SummaryWe are seeking a highly skilled Senior Data Engineer and QA Automation Specialist to join our Workplace Investing Quality Engineering team at Fidelity TalentSource LLC.About the RoleThis exciting new role within the Workplace Investing (WI) Data Engineering space requires a senior-level professional with expertise in designing, developing, and...


  • Durham, North Carolina, United States Phoenix Senior Living Full time

    About UsPhoenix Senior Living is a leading provider of senior care services, dedicated to delivering exceptional support and assistance to our residents.Job SummaryWe are seeking a highly skilled Med Tech / Certified Medication Aide to join our team. As a Med Tech, you will play a vital role in monitoring the health and well-being of our residents, providing...


  • Durham, North Carolina, United States Red Hat Full time

    We're looking for a talented Senior DevOps Specialist to help us drive innovation and excellence in our software development process. As a key member of our team, you'll work closely with technical leads and the business to understand feature requirements and break them down into manageable tasks.The estimated salary for this position is $130,000.00 -...


  • Durham, North Carolina, United States Actalent Full time

    Job Description:We are looking for a highly skilled Quality Assurance Engineer to join our software test development team. The ideal candidate will have experience in designing and developing test cases, automating test scripts, and working closely with development teams.Key Responsibilities:Design and develop test cases to verify software applications...


  • Durham, North Carolina, United States Corning Incorporated Full time

    Job Description:At Corning Incorporated, we're shaping the industries that shape our world. As a Quality Assurance Inspector, you'll play a vital role in ensuring the quality of our products meets the highest standards.About the Role:Perform in-process and final inspections of products to ensure compliance with specifications.Accept or reject products based...