Senior Quality Engineer, NPI

4 hours ago


Cork, Ireland Stryker Ireland Full time

Permanent contract role based on our Anngrove site What you will do Advocates and leads design for manufacture and assembly through technical leadership and direction in quality assurance, quality control and preventative activities. Supports the development and introduction of new products, processes, and technologies, with focus on quality systems development, regulatory compliance, and process risk management including pFMEA. Will develop and characterise processes that are capable, scalable and produce high yield. Will support the design of robust inspection strategies including CQA's, CTQ's and MSA's. Provide quality engineering support for the execution of quality assurance activities during design transfer phases of new product development. Will reside within the regional NPI QE team as part of GQO Quality Assurance organization and work collaboratively with Advanced Operations and Design Assurance, with responsibility for quality assurance activities, including, but not limited to the following: General Foster collaborative internal/external professional relationships across Design Divisions, Advanced Operations & GQO functions associated with design transfer activities. Communicate effectively with all internal customers, stakeholders, and project teams to deliver successful project transfers with the highest levels of quality that meet the NPI project goals. Mentor other groups and functions on areas of expertise with particular attention to design and process transfer. Risk Management Proficient in risk management practices and tools, having high expertise in failure modes associated with production and production related processes, (PFMEA). Support the Risk Management File through risk Management Principles. Responsible for the evaluation of process risks, risk mitigation and ensures appropriate production and process controls are identified, qualified, and implemented throughout the product manufacturing lifecycle (at supplier, incoming of materials/components, manufacturing, until product release) through robust pFMEA. Ensure all Risk Management outputs comply with ISO14971. Support Design team to complete CQA/CTQ identification and inputs to dFMEA to enable process risk identification, process characterization, process capability and robust process control. Inspection Develop and implement lean inspection strategies and inspection plans through state-of-the-art inspection methods and technologies. Ensure inspections are repeatable, efficient, and scalable. Lead continuous improvements of inspection methods and sampling plans, with a focus on human error risk elimination. Lead First Article Inspection (FAI) Strategies, both internally and externally, and approve First Article Inspections. Optimize inspection costs through lean initiatives while maintaining safety, integrity, and reliability of the product. Develop Measurement System Analysis (MSA) strategy and approve executed MSAs. Validation Support the development, execution, and approval of validation strategies, with the goal of highly capable processes, that result in high yield and enable scalability. Approve protocols and reports, including data analysis. Influence processes towards validation versus manual verification, where possible. Support Sterilisation validation activity, as required. Process Excellence Apply appropriate statistical techniques to ensure the development of robust, predictive quality systems which are easily transferable and maintainable in a production environment. Provide expertise for NC's & CAPA's related to new products. Act as a subject matter expert and mentor in problem solving and root causing tools. Support Design for Manufacture and Assembly (DFMA) through process design, inspection optimization, application of state-of-the-art technologies and tooling & fixture development. Support 'process bench marking' by providing quality experience as a process input. Will promote human factor error prevention and provide expertise in the science of human factor error risk identification and mitigation. Purchasing Controls Lead the supplier qualification strategy and approve the supplier validations and Production Part Approval Process (PPAP). Ensure Supplier's Quality Systems can complete process characterization and develop highly capable processes that are scalable, and meet Stryker expectations. Provide Quality input to influence the proper selection of suppliers. Support implementation of supplier certification. Support Supplier Quality to establish Quality Agreements with Stryker sites and suppliers as part of NPI projects. Design Transfer Represent quality assurance during the DTAP (Design Transfer Agreement Plan) process, ensuring product launches meet or exceed established metric targets including supplier DPM, right first time, manufacturing loss, manufacturing complaints per million, units recalled, product escapes and use-as-is, in conjunction with other targets per the DTAP. Provide subject matter expertise in Design transfer processes and procedures, participating and interfacing in internal & external audits with regulatory representatives. Represent NPI Quality Assurance at Design reviews and ensure integrity of the process design through robust NPI quality deliverables. Support device design into production specifications. Lead the efficient and timely transfer of lessons learnt knowledge to Quality engineering support, and regional peers. Provide expert quality process support post launch per DTAP agreement. Support the control of product, through appropriate system containment to guard against product escape during pre-released builds. What you need Bachelor of Science, Engineering or related subject with 4 years' experience in a quality or technical discipline or Masters of Science, Engineering or related subject with 2 years of experience in a quality or technical discipline Previous experience in a regulated environment within a manufacturing environment required. 2 years' experience in new product/process is a distinct advantage. #IJ To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.



  • Cork, Ireland Stryker Group Full time

    Senior Project Engineer - (Foot & Ankle, NPI) Role: Based in our Stryker Anngrove site in Carrigtwohill, Cork Hybrid Role What you will do: As a Sr. Project Engineer you will provide engineering support for New Product Introduction (NPI) process development ensuring that all activities are completed and documented in accordance with Stryker...


  • Cork, Ireland Sanmina Full time

    The company: As a medical device company, we help people in a truly tangible way. We are one of the most modern electronics factories, which gives us the opportunity to develop and build a career working with the latest technologies. The knowledge and skills you'll gain here are unique, and you'll find new challenges and endless opportunities along the way....


  • Cork, Ireland Cregg Recruitment Full time

    Manufacturing Engineer - Cork (Hybrid) About the role: Our Cork based client are now recruiting for a Manufacturing Engineer to join their team. An excellent opportunity to work with a thriving medical devices company. The successful candidate will be responsible for providing daily support of products, processes, materials, and equipment in order to achieve...


  • Cork, Ireland Claran Consultants Ltd Full time

    Senior Quality Specialist required for a leading Biopharma facility in Co. Cork, to provide Quality oversight, support and knowledge to activities relating to Quality Systems across the site and in meeting the priorities of: Compliance, Supply, Strategy and Profit Plan. Initially an 11 month contract. Please contact Claire The Quality Specialist will have...

  • Quality Engineer

    1 day ago


    Cork, Ireland Stryker Ireland Full time

    Position summary Develop basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures. Ensure compliance to regulation and standards. Who we want: Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes - finding...


  • Cork, Ireland Global Professional Consultants Full time

    Senior Engineer A Tier 1 Main Contractor is seeking a Senior Engineer to work on a Pharmaceutical Project in Cork. Duties: Verify the accuracy of calculations in plans, drawings, and quantities. Manage and interpret contract design documents from the client or architect. Collaborate with consultants, subcontractors, supervisors, planners, quantity surveyors,...


  • Cork, Ireland Global Professional Consultants Full time

    One of Irelands leading construction contractors, renowned for delivering large-scale infrastructure, commercial, and residential projects, is looking for a Senior Site Engineer to join their team in Cork City. This is an exciting opportunity to work with a top-tier company in a dynamic, fast-paced environment. Role Overview: The Senior Site Engineer will be...


  • Cork, Ireland Reperio Human Capital (Ireland) Ltd Full time

    Senior Test Engineer (€55k-€60k) Cork, Ireland (Hybrid) As a Senior Test Engineer, you will perform reviews and ensure the quality of the team's work as well as be able to participate and contribute on all team activities including sprint planning, daily scrums and retrospectives. Job Duties: Work closely with other developers and product owners to...


  • Cork, Ireland Stryker Corporation Full time

    The chosen candidate will provide quality leadership and direction in quality assurance, control, and preventative activities within operations and other business functions, focusing on preventative measures and continuous improvement of products and processes. Advocate and lead the execution of initiatives & projects to enhance quality performance within...

  • Senior Engineer

    1 day ago


    Cork, Ireland BAM Civil Full time

    Building a sustainable tomorrow We are currently seeking a Senior Engineer to join our Civil team in Co Cork. Your mission Conduct your work in a safe manner - correct and take responsibility to ensure that all works are carried out to the highest Health and Safety standards. Ensure work is carried out to the highest of quality standards and implement BAM's...

  • Quality Manager

    9 hours ago


    Cork, Ireland Collins McNicholas Recruitment Full time

    Join Our Team as a Quality Manager – Lead, Innovate, and Drive Excellence! Are you a Quality Management expert with a passion for continuous improvement and customer satisfaction? We are seeking a dynamic Quality Manager to lead our talented Quality Team at our Shannon site. Reporting directly to the General Manager, you will play a pivotal role in...

  • Senior Associate

    9 hours ago


    Cork, Ireland Eli Lilly and Company Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...


  • Cork, Ireland Motorola Solutions Full time

    At Motorola Solutions, we're guided by a shared purpose - helping people be their best in the moments that matter - and we live up to our purpose every day by solving for safer. Because people can only be their best when they not only feel safe, but are safe. We're solving for safer by building the best possible technologies across every part of our safety...

  • Senior Civil Engineer

    4 hours ago


    Galway, Cork, Ireland Snc-Lavalin Full time

    AtkinsRéalis is one of the world’s leading providers of engineering professional consulting and support services with offices across Ireland. We are seeking a Senior Civil Engineer to work in our dynamic civil infrastructure design team based in our Galway or Cork Office. The successful candidate will work in a structural team within a multidiscipline...


  • Cork, Ireland Johnson & Johnson Full time

    Job Description - Senior Engineer Network Manufacturing (2506229976W) Senior Engineer Network Manufacturing - 2506229976W Description Johnson & Johnson is currently seeking Senior Engineer Network Manufacturing MedTech to join our TEAM located in Ireland (Cork). At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation...


  • Cork, Ireland Amazon Group Full time

    The AML Programme team in Registration and Compliance (R&C, part of Selling Partner Risk) is looking for a quality control manager to lead, manage and develop a global team of quality specialists covering the Suspicious Activity Motoring and Screening programmes. The role is critical to ensure that Amazons payments businesses expand with appropriate controls...


  • Cork, Ireland NetApp, Inc. Full time

    Job Summary As a Senior Engineering Manager, you will plan, lead, and manage engineering and cloud services programs. You will lead a team of developers and QA engineers to implement, test and deliver high quality additions to our Cloud Volumes Service product in collaboration with our partners at Microsoft. Responsibilities will include: - A major part...


  • Cork, Ireland Stryker Ireland Full time

    Senior Staff Mechanical Design Engineer Location: Global R&D Innovation Centre, Cork Work Style: Hybrid This role is true R&D where you as a Snr Staff Engineer will be part of a group that has complete design control for all extremities power tools. In Cork, the team own the strategy and the portfolio. The team meet with the surgeons and gain a lot of...


  • Cork, Ireland Ward Personnel Full time

    On a full-time and permanent basis, the Quality Lead, working in the mechanical or HVAC field will be supported by the wider Project Management and Engineering teams. Key responsibilities of the role include, but are not limited to: Quality Control – Implement, improve, and maintain a robust quality management system to monitor and evaluate all phases...


  • Cork, Ireland Reperio Human Capital (Ireland) Ltd Full time

    Senior QA Automation Engineer (€60k-€65k) Cork, Ireland (hybrid) As a Senior QA Automation Engineer, you will kick off the day with a quick team meeting to discuss progress, roadblocks, and goals. You will be working with developers to build out automation while features are being developed. Key Requirements: 4+ years of experience in test automation...