QA Manager

2 weeks ago

Raleigh, United States IN-sight HR Full time

Essential Duties and Responsibilities

Oversee the quality management system, ensuring it aligns with regulations like ISO13485, MDR, and FDA 21 CFR Part 820.

Lead and empower the QA team, providing guidance, training, and direct support.

Track and analyze key quality metrics to identify areas for improvement.

Develop and refine quality procedures and protocols, guaranteeing their effectiveness, efficiency, and regulatory compliance.

Ensure all product-related processes, from manufacturing and inspection to release and distribution, are documented, validated, and meticulously controlled.

Conduct internal audits of the quality management system to verify regulatory adherence and pinpoint opportunities for enhancement.

Collaborate with the QA team to prepare for and participate in external audits by regulatory bodies.

Manage supplier relationships, including conducting audits, approving vendors, performing annual evaluations, and maintaining regular communication.

Spearhead data collection and trend analysis to inform the management review process.

Implement and manage the company’s corrective and preventive action (CAPA) process, including investigations, follow-up effectiveness checks, and trend analysis.

Lead the implementation of MRB, NC, and calibration procedures.

Investigate and resolve customer complaints.

Contribute to process validation and re-validation activities.

Guarantee that production and packaging operations, including sterilization, adhere to established procedures.

Participate in risk analysis activities.

Direct manager: VP QA/ RA

Additional Responsibilities

Stay up-to-date on the latest regulatory requirements and industry best practices for medical device quality assurance.

Identify and implement new technologies and methodologies to improve the efficiency and effectiveness of the QA program.

Develop and maintain strong relationships with internal and external stakeholders, including regulatory agencies, notified bodies, and suppliers.

Represent the QA department in cross-functional teams and meetings.

Requirements (Relevant Education/ Languages, Skills)

Bachelor’s degree in a relevant scientific or engineering field.

Minimum of 5 years’ experience as a QA Manager in a medical device company.

Experience in medical device manufacturing processes and clean rooms according to FDA 21 CFR Part 820, ISO 13485, MDR and relevant industry standards

Experience with Class III implants – big advantage

Experience in medical device manufacturing post-market activities for the US market

Lead Auditor certificate from a recognized institution

Experience in managing teams and developing quality systems.

Strong analytical, problem-solving, and communication skills.

Attention to detail and a commitment to quality.

Hebrew and English- high level – both written and verbal

#J-18808-Ljbffr

  • Sr QA Tester

    14 hours ago

    Raleigh, United States Crescens Full time

    Job Title : Sr QA Tester Location: Raleigh, NC Duration: 12+ months Type: Contract Job Description : This position is responsible for the following activities related to a critical system being developed in-house at the State: Experience assessing the testability of requirements and developing test cases based on Business Requirements and Software...

  • IT QA Test Lead

    1 week ago

    Raleigh, United States Cynet Systems Full time

    Job Description: Responsibilities: Lead the entire test management process. Report to and work closely with the QA Manager in creating and maintaining test plans, test strategies, and testing roadmaps, tracking, and reporting on testing progress, quality metrics, and milestones. Manage, direct, and coordinate SIT and UAT teams. Mentor and guide testing teams...

  • QA/QC Engineer

    1 week ago

    Raleigh, United States AtkinsRéalis Full time

    Join Us! Role: QA/QC Engineer Location: Raleigh, NC Role Overview Linxon is currently seeking a highly motivated Quality Assurance and Control Engineer to join our team in Raleigh, NC. The ideal candidate will be responsible for ensuring the highest standards of quality across EPC and substation projects. The Quality Assurance and Control Advisor will play a...

  • QA/QC Engineer

    2 weeks ago

    Raleigh, United States Linxon Pvt Ltd Full time

    Job DescriptionJoin Us!Role: QA/QC EngineerLocation: Raleigh, NCRole OverviewLinxon is currently seeking a highly motivated Quality Assurance and Control Engineer to join our team in Raleigh, NC. The ideal candidate will be responsible for ensuring the highest standards of quality across EPC and substation projects. The Quality Assurance and Control Advisor...

  • QA/QC Engineer

    4 days ago

    Raleigh, United States AtkinsRéalis Full time

    Join Us! Role: QA/QC Engineer Location: Raleigh, NC Role Overview Linxon is currently seeking a highly motivated Quality Assurance and Control Engineer to join our team in Raleigh, NC. The ideal candidate will be responsible for ensuring the highest standards of quality across EPC and substation projects. The Quality Assurance and Control Advisor will play a...

  • LU-SharePoint BA-QA

    2 weeks ago

    Raleigh, United States Focused HR Solutions LLC Full time

    The candidate will be allowed to work remotely until all staff return to site in Raleigh, NC . At that point, the candidate will be required to come onsite. The candidate will be required to use his/her own equipment until he/she is working onsite full timeOur client has an opening for a SharePoint BA-QA (715989)This position is for 12 months, with the...

  • Test Automation Architect

    2 weeks ago

    Raleigh, United States eTeam Full time

    Responsibilities Responsible for Defining QA strategy, approach and execution in development projects. Responsible for Leading and directing the QA leadership team. Provide leadership and technical expertise within Test Automation and Quality Assurance. Experience working on TOSCA SAP automation testing would be a big plus. Be accountable for the test...

  • Test Automation Architect

    14 hours ago

    Raleigh, United States eTeam Full time

    This role will build and manage a team of Automation, Functional, Performance and Load testers supporting all projects and programs. Responsibilities Responsible for Defining QA strategy, approach and execution in development projects. Responsible for Leading and directing the QA leadership team. Provide leadership and technical expertise within Test...

  • Epic Implementation Project Manager

    2 weeks ago

    Raleigh, United States Dice Full time

    Epic Implementation Project ManagerReports to the EHR Program Director and EHR PMO Manager.Work closely with the EHR Program Director, EHR PMO Manager, Application Manager, and other project managers to coordinate activities.Assist the EHR PMO Manager and Application Manager with the development of business cases for approval by the Information Technology...

  • Epic Implementation Project Manager

    2 weeks ago

    Raleigh, North Carolina, United States Dice Full time

    Epic Implementation Project ManagerReports to the EHR Program Director and EHR PMO Manager.Work closely with the EHR Program Director, EHR PMO Manager, Application Manager, and other project managers to coordinate activities.Assist the EHR PMO Manager and Application Manager with the development of business cases for approval by the Information Technology...

  • Technical Product Manager

    2 weeks ago

    Raleigh, United States CareerBuilder Full time

    Why We're Here: Industrial facilities around the world are facing unprecedented energy challenges around rising energy costs and carbon reduction goals. We help our customers measure and improve their carbon footprint, energy spend, and profitability in terms of their production. We call this Energy Intensity, and we do it with a "production first" mindset...

  • Technical Product Manager

    2 weeks ago

    Raleigh, United States Ndustrial Full time

    Job DescriptionJob DescriptionWhy We’re Here:Industrial facilities around the world are facing unprecedented energy challenges around rising energy costs and carbon reduction goals. We help our customers measure and improve their carbon footprint, energy spend, and profitability in terms of their production. We call this Energy Intensity, and we do it with...

  • Technical Product Manager

    3 weeks ago

    Raleigh, North Carolina, United States ndustrial Full time

    Why We're Here:Industrial facilities around the world are facing unprecedented energy challenges around rising energy costs and carbon reduction goals. We help our customers measure and improve their carbon footprint, energy spend, and profitability in terms of their production. We call this Energy Intensity, and we do it with a "production first" mindset...

  • Development (.NET) Manager

    2 weeks ago

    Raleigh, United States CareerBuilder Full time

    As the Development (.NET) Manager at Pierce Technology Corp, you will lead a team of talented .NET developers and oversee the planning, execution, and delivery of projects. You will work closely with cross-functional teams, including product managers, business analysts, and QA engineers, to ensure successful project outcomes. Additionally, you will be...

  • Roadway Design Project Manager

    2 weeks ago

    Raleigh, United States AEC Talent Acquisition Full time

    Our client is hiring! They are seeking a Roadway Design Project Manager. This role can be remote or located anywhere in NC. The successful candidate will provide designs, management, and execution of roadway engineering department projects. You will be responsible for managing project budgets and deadlines and for providing Quality Control efforts....

  • IT Senior BA Testing Lead

    3 weeks ago

    Raleigh, United States Serigor Inc. Full time

    Job DescriptionJob DescriptionJob Title: IT Senior BA Testing Lead (HYBRID)Location: Raleigh NCDuration: 12+ MonthsJob Description:The client is seeking a Senior QA/ Tester to perform QA and Testing work related to support the Managed Care Transition Project.This position is responsible for the following activities related to a critical system being...

  • IT Senior BA Testing Lead

    6 days ago

    Raleigh, United States Serigor Inc. Full time

    Job DescriptionJob DescriptionJob Title: IT Senior BA Testing Lead (HYBRID)Location: Raleigh NCDuration: 12+ MonthsJob Description:The client is seeking a Senior QA/ Tester to perform QA and Testing work related to support the Managed Care Transition Project.This position is responsible for the following activities related to a critical system being...

  • Development (.NET) Manager

    2 weeks ago

    Raleigh, United States Pierce Corporation Full time

    As the Development (.NET) Manager at Pierce Technology Corp, you will lead a team of talented .NET developers and oversee the planning, execution, and delivery of projects. You will work closely with cross-functional teams, including product managers, business analysts, and QA engineers, to ensure successful project outcomes. Additionally, you will be...

  • Development (.NET) Manager

    3 weeks ago

    Raleigh, United States Pierce Full time

    As the Development (.NET) Manager at Pierce Technology Corp, you will lead a team of talented .NET developers and oversee the planning, execution, and delivery of projects. You will work closely with cross-functional teams, including product managers, business analysts, and QA engineers, to ensure successful project outcomes. Additionally, you will be...

  • Development (.NET) Manager

    5 hours ago

    Raleigh, United States Pierce Full time

    As the Development (.NET) Manager at Pierce Technology Corp, you will lead a team of talented .NET developers and oversee the planning, execution, and delivery of projects. You will work closely with cross-functional teams, including product managers, business analysts, and QA engineers, to ensure successful project outcomes. Additionally, you will be...