Design Assurance Project Manager

3 months ago


Galway, Ireland VONQ Full time
Job Description

Nordson Medical, a global leader in the medical device industry, is seeking a Design Assurance Project Manager to join our team in Galway, Ireland, for a period of 6 months -3 days per week. We are committed to creating a diverse and inclusive workplace, and we are looking for candidates who share that same commitment. 

Summary of the role 

As a member of our team, you will have the opportunity to work in a dynamic and collaborative environment, where your ideas and contributions will be valued and respected.  

As a Project Manager you will be responsible for assuring product quality, safety and effectiveness

Role and Responsibilities

  • Lead Quality Representative on projects, directly contributing and/or providing guidance to others to establish appropriate Design History File / Device Master Record documentation. Providing detailed planning for clinical, pilot production and scale-up plans in New Product Introduction programs.

  • Ensuring project teams are utilizing Nordson Medical Quality Systems and appropriate regulations and industry standards throughout the product development process.

  • Investigating and evaluating material biocompatibility and appropriate methods of sterilization during the product design cycle.

  • Conducting risk assessments of the design to determine ability to function as intended. 

  • Responsible for timely Corrective and Preventative Actions (CAPA), change control and notification, internal and vendor audits, product release, document control, design control process and design history files (DHF), device master records, etc.

  • Interacting with customer and supplier companies in a professional manner; proactively communicating with them to ensure an ongoing two-way exchange of information. Auditing and qualification of new suppliers may be required.

  • Intervening and contributing to successful resolution of technical issues when they arise.

  • Ensuring that all work satisfies the requirements of the company's Quality Manual.

  • Continually looking for improvement and compliance improvement opportunities.

  • Leading Quality roles on client programs, assisting in the design and implementation of new methodologies, materials, machines, processes or products to bring concept to market, including essential product and process documentation. 

  • Maintaining detailed documentation throughout all phases of research and development, often leading documentation of user needs, product requirement and risk / test planning and execution activities.

  • Conducting and/or participating in meetings directly with clients.

  • Coordinating activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet scheduled timelines. May include supplier qualification and management.

Skills and Qualifications 

  • Minimum Bachelor's degree in Engineering or related field.

  • 10 years of medical device design and development/quality assurance experience is required.

  • Managing customer relationships and responses in aa timely manner.

  • Ability to interact with client companies in a professional manner.

  • Demonstrated ability to lead product verification & validation activities

  • Experience working with operations to develop strong manufacturing process instructions and operator training is desired.

  • Familiarity with process validation is required.

  • Familiarity with FDA QSRs, medical device regulations and ISO 13485

  • Familiarity with Metrology and ISO 17025 requirements

  • Knowledge of probability and statistics.

  • Organised and able to self-manage project tasks.

  • Customer focus with excellent communication skills, written and oral.

  • Depth of knowledge in one or more clinical areas.

  • Depth of knowledge in one or more specialized areas, e.g. Biocompatibility, sterilization methods, etc.

  • Experience using an electronic quality management system (eQMS) a plus.

  • Lean or Six Sigma certification/experience preferred.

  • Auditor experience preferred (i.e. Supplier, Customer, Third Party, Quality Management System (QMS))

  • Flexibility, persistence, resourcefulness, a drive to succeed, and an entrepreneurial spirit.

About Nordson Medical 

At Nordson Medical, we value diversity and inclusivity in all aspects of our business. We are an equal opportunity employer and welcome candidates of all backgrounds, experiences, and perspectives to apply.  

We are committed to ensuring a fair and equitable interview process, and our recruitment process is designed to identify the best qualified candidates for the role. We are looking for candidates who have a passion for inclusion, diversity and equity, and the ability to contribute to a culture where all employees feel valued, respected, and included. 

Interested? 

If you are interested in being a part of a team that is dedicated to improving the lives of patients through innovative medical technology and creating an inclusive and diverse workplace, please apply online with your CV. 

#LI-CM1

#VONQ



  • Galway, Ireland Nordson Corporation Full time

    Collaboration drives Nordson’s success as a market leader in Industrial Precision Solutions and Advanced Technology. Our employees thrive in an environment where we help each other reach our personal best and enable our company to continuously improve and grow, and our customers to succeed. You will find Nordson employees sharing our success by giving...


  • Galway, Ireland Boston Scientific Full time

      Our Mission:  At Boston Scientific Galway, we are dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world.We work collaboratively to solve healthcare’s toughest problems by developing solutions that matter most to those suffering from debilitating and life-threatening conditions and to...


  • Galway, Ireland Vickerstock UK Full time

    Vickerstock is working in partnership with a Tier 1 house building contractor to recruit a Technical Design Manager for a 2 year Fixed Term Contract Your new role as Technical Design Manager Review and manage design prior to tender Agree design deliverables and programmes Aim to minimise cost and maximise value Manage external consultants and subcontractors...


  • Galway, Ireland CK Group Full time

    Senior Design Quality Engineer Overview: CK QLS are recruiting a Senior Design Quality Engineer, to join our clients team for a 12-month project with potential extension. The role will be based in a hybrid setting in Galway, Ireland, with 3 days on-site work per week. The ideal candidate will have 5-8 years of experience in Quality Assurance for medical...


  • Galway, Ireland Gertek Project Management Full time

    We are seeking a talented Controls Engineer with expertise in Omron PLC programming and automation experience. The ideal candidate will be responsible for designing, developing, and implementing control systems to improve efficiency and productivity in our manufacturing processes. Responsibilities: Design, develop, and implement control systems using Omron...


  • Galway, Ireland Boston Scientific Full time

    About the role: The Project Manager will play an integral part in Sustaining projects within the Structural Heart Valve franchise. Scope of projects includes all product support activities as it pertains to Acurate Aortic System from initial launch to product end of life across business units and manufacturing sites. Project size ranges from small...


  • Galway, Ireland Boston Scientific Full time

      Our Mission:   At Boston Scientific Galway, we are dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. We work collaboratively to solve healthcare’s toughest problems by developing solutions that matter most to those suffering from debilitating and life-threatening conditions...


  • Galway, Ireland RPS Group Full time

    Project Manager - Water We are currently recruiting a number of Project Managers to deliver client side services in the Water Sector . The successful candidate will be accountable for the delivery of major projects with a focus on the scope, budget, schedule and risk including for a major capital investment programme. The Project Manager will act as...


  • Galway, Ireland Sterling Engineering Limited Full time

    Technical Project ManagerI am excited to present an opportunity to join a dynamic and forward-thinking team in a fast-paced, evolving market. This role offers the chance to innovate, collaborate with cutting-edge technology, and work in alignment with industry best practices.As a Project Manager within the team you will need strong technical expertise,...

  • Design Coordinator

    2 months ago


    Galway, Ireland BAM Building Full time

    Building a sustainable tomorrowWe are recruiting for a Design Coordinator to join our building team on a project based in Co. Galway. Your mission•    Engage in a purposeful and well organised manner with BAM’s Design & Build (D+B) Design Team (DT) and other team member.•    Manage design delivery project documentation.•    Treat Health...

  • Deputy Project Manager

    7 months ago


    Galway, Ireland SNC-Lavalin Full time

    Job Description AtkinsRéalis is one of the world’s leading providers of engineering professional consulting and support services with offices across Ireland. AtkinsRéalis is currently seeking a Deputy Project Manager to join the Transportation team based in Dublin, Dundalk, Cork or Galway office. We focus on innovative design and technical...


  • Galway, Ireland AECOM Full time

    Job DescriptionJob DescriptionAs a Project Manager you will be expected to work with a Senior Project Manager, Associate or Director to successfully manage, coordinate and deliver projects.The role will cover the whole project lifecycle from initial inception, through the design and procurement process and onto the site delivery and commissioning phase.The...


  • Galway, Ireland AECOM Full time

    Job DescriptionStart here. Grow here.  At AECOM, we are currently recruiting for a Construction Project Manager to join us at our Galway or Cork office.Here’s what you’ll do: Your day-to-day will include but not be limited to the following tasks and responsibilities;The role will cover the whole project lifecycle from initial inception, through the...


  • Galway, Ireland Nayr Recruitment Full time

    Project Manager - Infrastructure Client side Project Management of major Capital projects based in Galway city. These services include design, specification, project management, supervision and procurement associated with major and minor capital building and refurbishment works, infrastructural risk and asset management, property services, fire, health and...

  • Project Planner

    5 months ago


    Galway, Ireland RPS Group Full time

    Project Planner RPS is seeking to recruit a qualified  Project Planner  with proven professional experience in all areas of planning. This is a hybrid role with offices available in Dublin, Cork and Galway.Our projects are all around you. We define, design and manage projects that create shared value to a complex, urbanising and resource-scarce world....

  • Project Manager

    2 months ago


    Galway, Ireland BAM Building Full time

    Building a sustainable tomorrowWe are currently recruiting for the position of a Project Manager for our building division, on a project based in Co.Galway.Your missionPlan, organize, and direct activities concerned with the construction of structures, facilities, and systems.Develop project plans and schedules and execute plans to achieve agreed...


  • Galway, Ireland TEAM HORIZON Remote Work Freelance Full time

    Description Project Manager   Team Horizon is seeking a Construction Project Manager based in Galway for the management and planning of capital projects nationwide.     Why you should apply: They put their people first and live their diversity and inclusion values embracing all perspectives. You enjoy working in a culture of learning and...

  • Senior Research

    3 months ago


    Galway, Ireland Pale Blue Dot® Recruitment Full time

    Our client, an exciting multidisciplinary medical device start-up based in Galway is hiring a Senior Research & Design Engineer. The successful candidate will report to the R&D Project Lead and will get the opportunity to apply engineering knowledge in areas such as design, test method development and validation, CAD and...


  • Galway, Ireland Life Science Recruitment Ltd Full time

    Job title:Project Manager - R&D Location:Ballybrit, Galway Benefits:Excellent salary, bonus, pension, healthcare, hybrid working and opportunity to grow your career with hugely exciting Medical Device organisation. Company: My client are a Medical Device company who have recently been acquired by a multinational, a global leader in neurovascular care. And a...


  • Galway, Ireland Hewlett Packard Enterprise Full time

    Job Description: Hewlett Packard Enterprise is hiring a Product Design Intern, where you will be contributing to the design and usability of features of HPE’s GreenLake Platform and Software as a Service (SaaS). You will work closely with fellow designers, product managers and engineers to understand our users and their workflows to design...