Job Description
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 differently to solve problems, make progress, and deliver meaningful innovations. Our Purpose At our Manufacturing Facility, we focus on meeting customer and patient needs every day. Our focus is on delivering the highest levels of quality products to our patients. We do this through the development and operation of manufacturing processes to the highest levels of efficiency and performance. We achieve our aims through our people, our high performing teams. We focus on the development of innovative medical devices in Airway Management but also for other life enhancing applications. In this exciting role as Quality Validation Engineer, you will directly support the strategic automation and capacity enhancement program. Come for a job, stay for a career! A Day in The Life of Responsibilities may include the following and other duties may be assigned: Provide Quality support for new equipment development projects. Design/author/review/approve/execute qualification/validation documentation and cycle development studies in line with the standard approval process. Risk Management - as part of a team, support the completion of Risk Management to include the use of tools such as Failure Modes Effect Analysis (FMEA), Fault Tree Analysis. Establishes the quality and compliance requirements for new manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling, fabrication of tools and equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Resolving technical issues encountered during study execution. Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements. Suggest relevant changes to procedures and update to standard operating procedures as necessary. Engagement with production, maintenance, and quality representatives in the assigned area of operations during execution of cycle development & qualification activities. Liaise with cross functional team members, developing strong partnering relationships with these to establish inspection methods which ensure effective product acceptance activities. Participate in preparing/critically reviewing/approving NCMRs/CAPAs/Investigations and validation activities, providing expert QA technical direction and solutions as appropriate. Interacts with internal and external stakeholders in the processing of all quality and compliance activities and documentation ensuring our right-first-time culture prevails. Travel required 10-15% of the time for this role. Key Skills & Experience Level 8 Degree in a relevant Quality/Engineering/Science related discipline. Preferably with 3+ years relevant experience in a medical devices or similar regulated environment. Working Knowledge of plastic processing techniques such as Extrusion, Injection Moulding, Blow Moulding, Assembly, etc. Medical Device Process Validation and Knowledge, understanding and implementation of GAMP5 experience a distinct advantage. Knowledgeable in Quality Systems, validation standards, policies, procedures and methodologies. Experienced with practical working knowledge of statistical data analysis and quality improvement tools and techniques. A dynamic team-player and problem solver who can work effectively on cross-functional teams. Ability to be self-directed and to effectively interface with various levels and functions within the organization. Focused on patient and customer and set high standards, instill operational excellence, and drive accountability. Excellent written, documentation, and oral communication skills and are fluent in English, both written and spoken. Excellent organizational skills and can prioritize and work effectively on multiple projects. Medtronic offer a competitive salary and flexible Benefits Package #IJA 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.