Wallace Myers International | Senior Quality Engineer- Start-up

5 days ago


Galway, Ireland Wallace Myers International Full time

Position Title: Senior Quality Engineer Position Summary To provide QA technical and compliance expertise as part of teams tasked with establishing and assuring system and quality objectives. Assure compliance to applicable regulations. Lead quality activities such as audits, procedure development, documentation review and define changes to controlled documents. Provide QA technical and compliance support for products and manufacturing related to suppliers, corrective and preventive actions, product/process improvements and training. Responsibilities Responsible for compliance with company Policies and Procedures and applicable International Regulations Leads and/or facilitates compliance and improvement activities associated with the quality system (e.g. CAPA, audit programs, personnel training). Monitor compliance with companies policies, procedures and applicable regulatory requirements, identifying, reporting and implementing process and system improvements. Apply thorough, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Plan, execute, report and follow-up on quality system audits. Act as an audit escort and/or support in the coordination of backroom activity during inspections as required. Demonstrate an ability to apply, recommend and/or create quality tools and apply them effectively to a variety of business situations related to project and team environments, including contributing towards the generation of risk management file documents; Risk Management Plan, dFMECA, and associated reports. Represent company professionally and positively externally to agencies, vendors, and regulators. Team member for the implementation of QMS electronic systems. System Administrator for Greenlight Guru. Other responsibilities will include (but are not limited to) the following: Actively participates in and supports departmental activities and responsibilities in accordance with existing procedures and external regulations. Makes decisions that are aligned with management objectives regarding work processes, plans and schedules in order to achieve quality objectives. Resolves project issues by working with team members, suppliers, and others as appropriate. Provides technical quality guidance to the team as required. Essential Skills / Experience 5 years minimum QA, Quality System or regulatory experience in the medical industry a prerequisite. Auditor certification from an industry recognized organization is beneficial. Knowledge of FDA's 21 CFR Part 820 (Quality System Regulation) and ISO Experience in the QA activities associated with the design and development of medical devices.y. Results and deadline driven with an ability to handle multiple tasks and operate in a fast-paced environment. Excellent interpersonal skills and ability to work with people to achieve results. Excellent written and communication skills, fluency in English. Experience in preparation for notified body and FDA inspections. Good judgment/decision making and problem-solving ability, capable of understanding the impact of decision making on both company and their customers. Highly motivated and an enthusiastic self-starter with the ability to work under own initiative and as a team player. Proficiency in MS office products. Good business acumen. At Wallace Myers International Recruitment Agency we specialise in sourcing professionals for key industries and services. See our website for more details. Privacy Policy: By applying for this role you are agreeing that your details will be stored in our database and may be considered for similar future positions. For more info see Skills: Quality Assurance Design Assurance Medical Devices



  • Galway, Ireland Wallace Myers International Full time

    My client who are an exciting Galway based medical device start-up are seeking an experienced Quality Engineer to join their team. This position requires 3+ years' experience and a proven track record in Quality and Regulatory control of medical devices. This role will focus on ensuring product quality during early development phases through to commercial...


  • Galway, Ireland Wallace Myers International Full time

    About the Role: Our client is seeking an experienced Pharmacy Technician to join their team in Galway. The role is full-time (part-time 3/4 days a weeks is also an option), requires 1 Saturday in 4 AND 1 late night per week until 8PM. No Sundays or Bank Holidays. System used is MPS. Responsibilities Preparing and dispensing medicines under the supervision of...


  • Galway, Ireland Wallace Myers International Full time

    A leading Irish based organisation, headquartered in Galway are looking for a HR Manager to join their growing team. Role Overview: As the HR Manager, you will be responsible for overseeing the day to day running of the HR function and operations. Reporting to the Head of HR and working closely with the SLT. your role will be vital in supporting staff...


  • 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 Nordson Full time

    Job DescriptionNordson Medical, a global leader in the medical device industry, is seeking an experienced and highly motivated individual to join our team in Galway, Ireland as a Senior Quality Engineer. We are committed to creating a diverse and inclusive workplace, and we are looking for candidates who share that same commitment. Summary of the roleThe...


  • Galway, Ireland Abbott Full time

    About Abbott Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160...

  • Quality Engineer II

    3 weeks ago


    Galway, Ireland Pale Blue Dot® Recruitment Full time

    Our Client, an exciting medical device start up in Galway City is hiring a Quality Engineer. The successful candidate will support process quality and design assurance. The level of seniority can be tailored to the expertise of the suitable candidate.  Collaborating closely with R&D, Clinical, Regulatory, and Manufacturing Engineering teams, you will...


  • 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...

  • Quality Engineer II

    7 days ago


    Galway, Ireland Sterling Engineering Limited Full time

    Quality Engineer II Responsibilities:Ensure compliance with customer and regulatory quality systems (ISO 13485, FDA).Develop and maintain effective inspection plans for incoming, in-process, and final products.Investigate and resolve quality issues, including customer complaints, using CAPA systems.Assess product/process changes for validation and quality...


  • Galway, Ireland Medtronic Vascular Galway UC Full time

    At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Medtronic At Medtronic, we value what makes you unique. Be part of a company that thinks...


  • Galway, Ireland Medtronic Full time

    Medtronic At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress and deliver meaningful innovations. Our Purpose  At our Quality Department in Medtronic, plc, we focus on supporting the product to ensure that customer & patient needs are met every day. Our key focus is on delivering...


  • Galway, Ireland Medtronic Vascular Galway UC Full time

    At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Medtronic At Medtronic, we value what makes you unique. Be part of a company that thinks...

  • Quality Engineer

    4 months ago


    Galway, Ireland Abbott Full time

    About Abbott Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160...

  • Quality Engineer II

    4 months ago


    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...

  • Quality Engineer II

    4 weeks ago


    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 CVS Health Ireland Full time

    CVS Health, the parent company of Signify Health, is increasing investments in digital, data, analytics and technology and Signify Health is excited to be involved! We are hiring for a dynamic new initiative for CVS Health that will run out of our state-of-the-art offices at Bonham Quay. This is your opportunity to be involved with a pioneering business that...


  • 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 the...

  • 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 Kate Cowhig International Healthcare Recruitment Full time

    Overview: The Recruitment Coordinator will be required to support the recruitment of international healthcare staff for permanent placements with our clients in Ireland and the UK. The ideal candidate will be outgoing, personable and a problem solver with a positive, enthusiastic attitude and is willing to be a team player. This role is fast paced and would...


  • Galway, Ireland SISK Constuction Ireland Full time

    #IJ Specializing in the design, manufacture, and installation of 2D panelised and 3D volumetric modular structures. Vision-Built's award winning system means clientele have the peace of mind knowing, when they choose Vision-Built, they're choosing a company that exceeds expectations. With over 30 years' experience in off-site construction, we pride ourselves...