Principal Supplier Quality Engineer

2 weeks ago

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 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 Supplier Quality Department in Medtronic, plc, we partner with Medtronic's suppliers to deliver the highest quality and most reliable products to our customers within the Diabetes organization. The Principal Supplier Quality Engineer (SQE) works with a Supplier Quality team who works with external suppliers and in a cross-functional Medtronic team on a daily basis to resolve supplier related issues, drive continuous improvement while driving key quality metrics. They SQE will liaise with our extensive network of suppliers to execute on PPAP validations, quality improvements, cost savings, while managing and implementing Supplier driven changes. Come for a job, stay for a career A Day in The Life Of: Ensures that suppliers deliver quality parts, materials, and services. Provide Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with Medtronic cross functional teams, contract Manufacturers and suppliers to deliver quality parts, materials, and services, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products. Qualifies and onboards suppliers according to company standards during NPD pre-production and development phases, to ensure high supplied product yields and reliability. Executes validation activities at supplier to Medtronic requirements ensuring high product reliability and confidence and resolves supplier-related problems as they occur. Develops and prioritizes a supplier auditing schedule during NPD to ensure that designated suppliers are audited and onboarded to the Diabetes ASL per Medtronic requirements and ensure good manufacturing practices (GMP) and quality standards are met Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation. Builds a collaborative relationship with suppliers to quickly address any Drive appropriate root cause investigations with the supplier. Ensure Corrective actions are implemented and monitor for desired results. Drive supplier improvement/corrective action through the following Work with the supply base to drive corrective/preventative action based on feedback from incoming inspection, Medtronic/supplier internal quality metrics and customer complaints. Coordinate and monitor change control process (including review and approval) to ensure performance, compliance and regulatory requirements are met and properly documented. Review/prepare test plans and reports (qualification, validation) for change and improvement activities (supplier certifications, material/sub-supplier changes and supplier performed special Provide technical assistance to suppliers/other resources performing qualification/validation testing. Ensure the resolution of all issues raised during testing/qualification. Collaborates with the operating platform to address issues and gain alignment when required. Represent the Supplier Quality group in operating meetings providing status updates on supplier base. Support supplier visits or audits as required. Support external regulatory and internal audits as required. You will work with supplier and sub-tier suppliers, as required, to lead and drive systematic approaches and ensure stability related to medical device Work with the Enterprise Supplier group supporting creation of supplier related metrics for the purposes of tracking vendor performance and identifying opportunities for improvements. Define Receiving Inspection requirements as required and associated test method validation where required for internal Medtronic Test Methods. Key Skills & Experience Qualified to Level 8 in Science, Engineering, or relevant discipline. 7+ years Engineering and/or Quality experience in the medical industry or related field, or Level 9 degree with 5+ years' experience. Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience. Experience with Process Validations and/or Test Method Validations (For Example: IQ, OQ, PQ, and/or TMV). May have broad knowledge of project management. You are a dynamic team player and can work effectively and proactively on cross functional teams. Experience with Agile, SAP & Microsoft Project an advantage. Excellent problem-solving skills are desirable. You are a good communicator and fluent in English, both verbal and written. Nice to Have Knowledge of regulatory requirements and guidelines including 21 CFR parts 210, 211, 21 CFR part 820, ICH requirements and ISO 13485 requirements is an advantage. Previous experience in Supplier Quality and leading teams ISO 13485 Lead Auditor Certification. Experience with knowledge in Lean Principles. Medtronic offer a competitive salary and flexible Benefits Package #IJ Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 90,000+ passionate people. We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here 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.

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