Sr. Quality Engineer Psur

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 A Day in the Life Prepare and compile product post market data and findings into comprehensive Periodic Safety Update Reports PSURs in compliance with regulatory requirements Serving as a mentor to junior engineers providing guidance and support in quality engineering practices within the realm of medical devices Must Have Collaborate with cross-functional teams to gather and analyze data related to the performance and safety of medical devices and independently develop Periodic safety update plan and reports Partner with regulatory affairs and medical experts to ensure accurate and timely submission of PSURs to regulatory authorities Continuously monitor and stay updated with evolving safety regulations and guidelines to ensure PSUR compliance Familiar with Literature review PMCF IMDRF coding CAPA and NCMR Develop templates and trainings based on the quality system regulations applicable standards and guidance Independently review all deliverables to ensure compliance with development process and the standard Deliver presentations to the QA organization on status and issues of assigned projects Deliver trainings to departments outside of QA Demonstrates ability to effectively play multiple roles on a cross-functional team including contributor subject matter expert leader facilitator Hands-on experience on EU MDR Previous experience working in a cross-functional team environment Hands-on experience on Risk Management Design Controls for Medical Devices Participate when appropriate in audits Familiar with ISO 13485 ISO 14971 and EU MDR and product specific industry standards Experience in collaborating with regulatory affairs teams for submission of safety reports Minimum Qualification B E or B Tech in Mechanical Biomedical Engineering Minimum 5-8 years of quality engineering experience or equivalence and overall 8-12 years of experience Key Technical Competencies Understanding of post-market surveillance processes and adverse event reporting Knowledge of risk management principles and hazard analysis in the context of medical devices Familiar with ISO 9001 ISO 13485 ISO 14971 21 CFR part 820 21 CFR part 11 EUMDR and product specific industry standards Familiar with DMAIC or DMADV DFSS methodologies Good verbal and written communication skills including plan report development Working knowledge of and auditing experience to the FDA Quality System Regulation ISO 13485 and the Medical Device Regulation Nice to Haves ASQ CQE CQA CSQE and or CRE certification ISO 13485 Internal Auditor Lead Auditor Certification Lean Six Sigma Green Belt or Black Belt 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 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 95 000 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