Quality Assurance Manager for Medical Devices

3 weeks ago


Raleigh, North Carolina, United States Automationtechies Full time

Automationtechies is seeking a highly skilled Quality Assurance Manager to lead our medical device quality initiatives. This role will be responsible for managing and implementing our Quality Management System (QMS) to ensure compliance with cGMP, ISO 13485, and other applicable standards.

The ideal candidate will have experience in managing quality systems, implementing and leading internal and external audits, and developing and implementing manufacturing standard operating procedures (SOPs). They will also be responsible for establishing and managing safety and regulatory requirements for equipment, facility, and personnel.

Key responsibilities will include:

  • Managing and implementing QMS and compliance with cGMP, ISO 13485, and other applicable standards
  • Developing and implementing manufacturing SOPs, policies, procedures, tools, and templates
  • Establishing, training, and managing safety and regulatory requirements for equipment, facility, and personnel
  • Providing additional expertise and assistance in production operations, safety, customer service, etc.

The successful candidate will have a strong background in quality engineering and management, with experience in medical devices or components sold into medical devices. They will also have excellent communication and presentation skills, with the ability to work effectively within a high-caliber team and influence others.

Automationtechies offers a fast-paced and dynamic work environment, with opportunities for growth and development. If you are a motivated and detail-oriented individual with a passion for quality and excellence, we encourage you to apply for this exciting opportunity.



  • Raleigh, North Carolina, United States The Mullings Group Full time

    Electrical Engineering Manager for Medical DevicesThe Mullings Group is seeking an experienced Electrical Engineering Manager to join our team in the medical robotics arena. As a key member of our Global R&D team, you will play a crucial role in developing state-of-the-art medical devices.Key Responsibilities:Lead and manage a team of electrical engineers,...


  • Raleigh, North Carolina, United States Veeva Systems Full time

    Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster.We are committed to making a positive impact on our customers, employees, and communities.The successful candidate will lead our QA team for the Digital Trials Platform, working with Development Managers and Product...


  • Raleigh, North Carolina, United States Focused HR Solutions Full time

    Job Title: IT Quality Assurance ManagerThis is a remote job opportunity for a highly skilled IT Quality Assurance Manager. The position is currently based in Raleigh, NC, but may transition to an on-site location in the future.We are seeking a professional with 5+ years of experience in Enterprise IT Systems, system integration principles, and associated...


  • Raleigh, North Carolina, United States SpringWorks Therapeutics Full time

    About SpringWorks Therapeutics:SpringWorks Therapeutics is a commercial-stage biopharmaceutical company dedicated to developing and delivering life-changing medicines for people with severe rare diseases and cancer. Our precision medicine approach enables us to rapidly advance our lead product candidates into late-stage trials and collaborate with innovators...


  • Raleigh, North Carolina, United States SpringWorks Therapeutics Full time

    About SpringWorks Therapeutics:SpringWorks is a commercial-stage biopharmaceutical company that applies a precision medicine approach to developing and delivering life-changing medicines for people with severe rare diseases and cancer.The company has a diversified targeted oncology pipeline spanning solid tumors and hematological cancers, including clinical...


  • Raleigh, North Carolina, United States Acentra Health Full time

    Job DescriptionAcentra Health is seeking a highly skilled Software Quality Assurance Test Manager to lead our team in ensuring the highest quality software solutions.Key Responsibilities:Lead and manage the Software Quality Assurance team, providing guidance and oversight to ensure consistent quality across all projects.Develop and implement effective test...


  • Raleigh, North Carolina, United States Bayone Full time

    Job SummaryWe are seeking a highly skilled Senior Software Quality Assurance Engineer to join our team at Bayone. As a key member of our software development team, you will be responsible for developing and implementing software testing strategies and methodologies to ensure the highest quality of our medical device products.Key ResponsibilitiesDevelop and...


  • Raleigh, North Carolina, United States GlaxoSmithKline Full time

    Job DescriptionWe are seeking a highly skilled Quality Assurance Specialist to join our team at GlaxoSmithKline. As a key member of our quality assurance team, you will be responsible for ensuring the quality and integrity of our computerized systems.Key Responsibilities:Provide quality oversight to support the implementation and maintenance of strategic...


  • Raleigh, North Carolina, United States Focused HR Solutions Full time

    Job Description:Focused HR Solutions is seeking an experienced IT Quality Assurance Lead to join our team. As a key member of our IT Division, you will be responsible for ensuring the development of high-quality outcomes and deliverables for the Medicaid Enterprise System (MES) project.The ideal candidate will have a strong background in IT and healthcare...


  • Raleigh, North Carolina, United States Wake Research Full time

    Job SummaryM3 Wake Research, an M3USA Company, is seeking a Senior Quality Control Manager to support the implementation of quality initiatives. The successful candidate will conduct audits to ensure compliance with Standard Operating Procedures (SOPs), local and federal regulations, ICH-GCP guidelines, and specific protocols as needed.Key...


  • Raleigh, North Carolina, United States V Group Inc. Full time

    Job Title: Software Quality Assurance SpecialistJob Description:We are seeking a skilled Software Quality Assurance Specialist to join our team at V Group Inc. The ideal candidate will have experience in software testing, quality assurance, and project management.Key Responsibilities:Review and analyze project requirements for clarity and...


  • Raleigh, North Carolina, United States ManpowerGroup Full time

    Job Title: Quality Assurance EngineerJob Summary:The client is seeking a Quality Assurance Engineer with expertise in Kubernetes and MLOps to join their rapidly growing engineering team. The team focuses on creating a platform, partner ecosystem, and community to accelerate business success using AI. This is an exciting opportunity to build and impact the...


  • Raleigh, North Carolina, United States TRANZACT Full time

    Job Title: Quality Assurance SpecialistAt TRANZACT, we are seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring the sales and enrollment activities of our marketing staff comply with legal and regulatory requirements, carrier-specific requirements, and adherence...


  • Raleigh, North Carolina, United States TRANZACT Full time

    Job Title: Quality Assurance SpecialistAt TRANZACT, we are seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for monitoring the sales and enrollment activities of our marketing staff to ensure compliance with legal and regulatory requirements.Key Responsibilities:* Monitor sales...


  • Raleigh, North Carolina, United States Focused HR Solutions Full time

    Job Title: Quality Assurance TesterLocal to Raleigh, NC only. This job is remote, with occasional on-site requirements. Our client has an opening for a Quality Assurance Tester. The position is up to 12 months, with the option of an extension, and the client is in Raleigh, NC.$40-47c-c or $35-42w2Demonstrated proficiency in conducting QA and testing of web...


  • Raleigh, North Carolina, United States Ndustrial Full time

    About the RoleNdustrial is seeking a skilled Quality Assurance Automation Engineer to join our feature development team. As a key member of our team, you will be responsible for ensuring the quality and reliability of our Nsight Energy Intensity Platform by designing, implementing, and executing both manual and automated test strategies. You will work...


  • Raleigh, North Carolina, United States ClinLab Staffing Full time

    Key Responsibilities:Review and update Standard Operating Procedures (SOPs), quality control records, and compliance documentation to ensure adherence to regulatory requirements.Collaborate with the Quality Lead and Operations team to develop and implement design control and risk management strategies.Compose and submit audit responses to internal quality...


  • Raleigh, North Carolina, United States Top Tier Reps LLC Full time

    Job DescriptionAs a Medical Device Sales Representative with Top Tier Reps LLC, you will be responsible for selling medical equipment to hospitals, health systems, doctor's offices, and clinics. Your primary goal will be to establish strong relationships with medical staff and educate them on the benefits of our medical devices.Key ResponsibilitiesDevelop...

  • Quality Manager

    4 weeks ago


    Raleigh, North Carolina, United States Management Business Solutions Full time

    Are you looking for a challenging role in Quality Engineering and Management? Our client, Management Business Solutions, is seeking a highly motivated Quality Engineer with experience in industries like medical devices, CNC machining, aerospace, or automotive manufacturing, and 3D printing. In this role, you will be responsible for managing systems and...


  • Raleigh, North Carolina, United States Piper Companies Full time

    Piper Companies is a leading pharmaceutical organization specializing in diabetes care and other products and services.The company is seeking a highly skilled Validation Engineer to drive process improvement projects and collaborate with a team of engineers in Raleigh, NC.The ideal candidate will have a strong background in engineering and risk-based...