Senior QA/ra Associate

6 months ago

Belfast, United Kingdom Axial3D Full time

**Benefits**:
**Flexible working**:
**Generous annual leave allowance**:
**Company pension**:
**Potential to earn stock options**:
**Personal development**:
**Unlimited tea and coffee**:
**Senior QA/RA Associate**:
Axial3D is a leading provider of advanced medical imaging software solutions. Our cutting-edge technology is transforming the healthcare industry by enabling healthcare professionals to visualize and analyze medical imaging data in a more efficient and effective manner.

Headquartered in Belfast, Northern Ireland Axial3D provides solutions to over 300 hospitals, medical device manufacturers, and other healthcare companies around the world. Specializing in the delivery of 3D printed anatomical models and 3D visualizations and services to the healthcare sector, Axial3D provides machine learning-based solutions that support the integration of 3D patient-specific solutions into surgical care pathways and scaling patient-specific programs.

Ideal location for the position would be in Belfast.

**The Role**

As a senior QARA you will be responsible for improving and assisting implementation of the Axial3D Quality Policy and Procedures to facilitate company certification and compliance with ISO certifications. As Senior QA/RA Associate, you will work closely with the Quality Assurance and Regulatory Affairs team to improve processes and compliance of the Information Security and Quality Management System (IS & QMS).

You will promote awareness of the quality and customer requirements throughout the company, particularly with the Operations and Software Development teams responsible for producing patient-specific 3D anatomical models and files.

**You will assist with the following**:

- Ensure documentation of the processes needed for the support of quality management are in place
- Report on the performance of the QMS
- Report and manage NCR, CAPA and Change Controls identified within the company
- Assist with internal, external and supplier audits as required
- Reviewing and providing input to Post Market Surveillance and Vigilance processes
- Developing awareness and adoption of applicable standards throughout the organization

**You will also be responsible for**:

- Assisting and reviewing Medical Device Files, Technical Documentation and Device Master Records as required
- Maintain an up-to-date awareness of relevant legislation which may impact the QMS
- Facilitate productivity, process improvements and effectiveness across the organization
- Provide training sessions to ensure the understanding and compliance of all staff
- Promote the benefits of the quality system to all staff
- Facilitate and support the software engineering team with production of compliant Software as a Medical Device (SaMD) including
- Facilitate and support the Operations Team to ensure processes are in place for the controlled production of custom made patient specific 3D anatomical models and files
- Perform final QA release checks on products in preparation for dispatch

**For this opportunity you should have**:

- Experience of working with ISO 13485 including lead auditor certification is essential
- Minimum of 5 years experience working in a similar role in the medical device industry
- Experience in generation of technical documentation
- Awareness of medical device regulatory requirements including Medical Device Regulation (MDR) and FDA

**Education Requirements**:

- Bachelor's degree (or above) in a scientific or technical discipline
- Lead Auditor Qualified

**Other Requirements**:

- Strong communication and organizational skills
- Knowledge of ISO 14971, IEC 62304 and IEC 62366
- Awareness of Data and Information Security principles
- Awareness of global regulatory submissions and market access requirements

Axial3D is a rapidly growing and award-winning start-up and its success is built on the desire, determination, and talent of its employees. It’s a fun and growing team and Axial3D offers the opportunity for your ideas to be implemented and to be recognized and rewarded for your achievements. We are a diverse group of people committed to making a real impact on people’s lives. We build products for everyone and do not discriminate on gender, ethnicity, sexual orientation, religion, civil or family status, age, disability, or race.

We will get back to you as soon as we can to discuss the next steps.

  • Senior QA Engineer

    3 weeks ago

    Belfast, United Kingdom Baker McKenzie Full time

    Role Summary: As a Senior QA Analyst, you will be responsible for managing systems quality from planning quality measures during the requirements phase of a development project to drafting, managing, and executing functional testing processes. You will participate in requirements sessions, review requirements documentation, and ensure that systems under...

  • Senior Qa Engineer

    3 weeks ago

    Belfast, United Kingdom Ocho Full time

    Senior QA Engineer Hybrid Company Overview: My client is a fast-growing startup, backed by top-tier investors, focused on revolutionizing the post-sales experience for software companies.Their platform uses machine learning and advanced automation to drive user engagement, retention, and revenue growth, helping clients tap into the 90% of revenue generated...

  • Senior Qa Analyst

    3 weeks ago

    Belfast, United Kingdom Baker Mckenzie Full time

    Location: Belfast Workplace: Hybrid The opportunity: The Senior QA Analyst will manage systems quality ensuring high-quality internally developed solutions and integrations are delivered to the Firm's product owners and users.This role may provide feedback and recommendations (resolution and preventive action) to ensure systems introductions, enhancements,...

  • QA Tester

    2 weeks ago

    Belfast, United Kingdom Hayward Hawk Full time

    Senior QA Tester (Automation) Belfast Hybrid Hayward Hawk are currently recruiting exclusively for their client who are looking for an experienced Automation Engineer to join their team. The successful QA will be responsible for creating test cases, executing tests, identifying bugs and issues, helping developers reproduce and solve problems, and reporting...

  • Qa Tester

    1 week ago

    Belfast, United Kingdom Hayward Hawk Full time

    Senior QA Tester (Automation) Belfast Hybrid Hayward Hawk are currently recruiting exclusively for their client who are looking for an experienced Automation Engineer to join their team.The successful QA will be responsible for creating test cases, executing tests, identifying bugs and issues, helping developers reproduce and solve problems, and reporting on...

  • QA Tester

    1 month ago

    Belfast, United Kingdom Hayward Hawk Full time

    QA Tester (Automation) Belfast Hybrid Hayward Hawk are currently recruiting for a few clients who are looking for Senior Automation Engineers' to join their teams. The successful QA will be responsible for creating test cases, executing tests, identifying bugs and issues, helping developers reproduce and solve problems, and reporting on progress and quality...

  • Senior QA Engineer

    1 day ago

    Belfast, United Kingdom Search 5.0 Full time £40,000 - £55,000

    About the RoleWe're on the hunt for a seasoned Senior QA Engineer to drive quality assurance in our Belfast office. As a senior member of our team, you'll lead the development and execution of detailed test plans and cases for manual and automated testing, utilizing your expertise in Python scripting to maintain robust test automation frameworks. You'll also...

  • Senior QA Engineer

    2 months ago

    Belfast, United Kingdom Ocho Full time

    Senior QA Engineer- Hybrid (Belfast) Company Overview: My client is a forward-thinking start-up thats redefining the post-sales experience for software companies. Their automation platform leverages machine learning to drive user adoption, retention, and revenue growth, supporting enterprise clients in high-impact ways. Role Overview: In this role, youll...

  • Qa Tester

    3 weeks ago

    Belfast, United Kingdom Hayward Hawk Full time

    QA Tester (Automation) Belfast Hybrid Hayward Hawk are currently recruiting for a few clients who are looking for Senior Automation Engineers' to join their teams.The successful QA will be responsible for creating test cases, executing tests, identifying bugs and issues, helping developers reproduce and solve problems, and reporting on progress and quality...

  • QA Engineer Leader

    4 hours ago

    Belfast, United Kingdom Search 5.0 Full time

    Senior QA Engineer - Hybrid OpportunityWe are seeking a seasoned Senior QA Engineer to join our team in Belfast. In this role, you will be responsible for developing and executing comprehensive testing strategies, incorporating both manual and automated testing approaches.Your Key Responsibilities:Develop and execute test plans and cases for manual and...

  • QA Automation Specialist

    3 weeks ago

    Belfast, United Kingdom Ocho Full time

    Join Our Team as a Senior QA EngineerWe are looking for an experienced Senior QA Engineer to help us ensure the quality and reliability of our software products. In this role, you will work closely with our cross-functional teams to design, develop, and execute automated tests using various tools and technologies.About the Job:This is an excellent...

  • QA Automation Engineer

    3 weeks ago

    Belfast, United Kingdom Search 5.0 Full time

    Mid-Senior QA Automation Engineer - Belfast - Hybrid Search 5.0 is delighted to be partnered with a new and exclusive client in the form of an ambitious and innovative software consultancy start-up. Our client specialise in helping businesses mostly within the clean energy sector to bring complex projects to life through cutting-edge software solutions and...

  • QA Automation Engineer

    3 weeks ago

    Belfast, United Kingdom Search 5.0 Full time

    Mid-Senior QA Automation Engineer - Belfast - Hybrid Search 5.0 is delighted to be partnered with a new and exclusive client in the form of an ambitious and innovative software consultancy start-up. Our client specialise in helping businesses mostly within the clean energy sector to bring complex projects to life through cutting-edge software solutions and...

  • QA Automation Engineer

    1 month ago

    Belfast, United Kingdom Search 5.0 Full time

    Mid-Senior QA Automation Engineer - Belfast - Hybrid Search 5.0 is delighted to be partnered with a new and exclusive client in the form of an ambitious and innovative software consultancy start-up. Our client specialise in helping businesses mostly within the clean energy sector to bring complex projects to life through cutting-edge software solutions...

  • Senior Qa Engineer

    4 weeks ago

    Belfast, United Kingdom Ocho Full time

    QA Engineer Automation / Playwright / Postman About The Role Join an Ocho Exclusive Client as an QA Engineer. You will play a critical role in ensuring the quality, reliability, and performance of their software products through effective test automation and continuous process improvement About The Company My client is an innovative and expanding company...

  • Senior Qa Engineer

    2 weeks ago

    Belfast, United Kingdom Ocho Full time

    QA Engineer Automation / Playwright / Postman About The Role Join an Ocho Exclusive Client as an QA Engineer.You will play a critical role in ensuring the quality, reliability, and performance of their software products through effective test automation and continuous process improvement About The Company My client is an innovative and expanding company...

  • QA Automation Engineer

    1 month ago

    Belfast, United Kingdom Search 5.0 Full time

    Mid-Senior QA Automation Engineer - Belfast - Hybrid Search 5.0 is delighted to be partnered with a new and exclusive client in the form of an ambitious and innovative software consultancy start-up. Our client specialise in helping businesses mostly within the clean energy sector to bring complex projects to life through cutting-edge software solutions and...

  • QA Automation Engineer

    3 weeks ago

    Belfast, United Kingdom Search 5.0 Full time

    Mid-Senior QA Automation Engineer - Belfast - Hybrid Search 5.0 is delighted to be partnered with a new and exclusive client in the form of an ambitious and innovative software consultancy start-up. Our client specialise in helping businesses mostly within the clean energy sector to bring complex projects to life through cutting-edge software solutions and...

  • QA Automation Engineer

    1 month ago

    Belfast, United Kingdom Search 5.0 Full time

    Mid-Senior QA Automation Engineer - Belfast - Hybrid Search 5.0 is delighted to be partnered with a new and exclusive client in the form of an ambitious and innovative software consultancy start-up. Our client specialise in helping businesses mostly within the clean energy sector to bring complex projects to life through cutting-edge software solutions and...

  • QA Automation Engineer

    1 month ago

    Belfast, United Kingdom Search 5.0 Full time

    Mid-Senior QA Automation Engineer - Belfast - Hybrid Search 5.0 is delighted to be partnered with a new and exclusive client in the form of an ambitious and innovative software consultancy start-up. Our client specialise in helping businesses mostly within the clean energy sector to bring complex projects to life through cutting-edge software solutions and...