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 LifeMedtronicAt 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 Acute Care & Monitoring solutions, we empower healthcare professionals with world-class technology to personalize patient care, anytime, anywhere.
Our products can be found in various specialties: Respiratory Therapy, Critical care physicians and nurses, anesthesia, operating room, emergency medicine, first responders, hospital administration, operating room clinicians, and procedural sedation clinicians.In this exciting role as a Senior Quality Systems Engineer, one of development, improvement, and innovation, through cross functional collaboration.
If you pride yourself on your problem-solving skills, meticulous attention to detail and passion for quality this may be the role for you.
You will be tasked to provide quality systems engineering support in the development and maintenance of medical device products across the Acute Care and Monitoring (ACM) portfolio of products.
You will facilitate the application of our Quality Management System in developing and sustaining our product portfolio.A Day in The Life Of:Manage and drive the Corrective and Preventive Action (CAPA) Program.Including ownership of the investigations, Root Cause Analysis and resulting Corrective and Preventive Actions, and developing sound effectiveness check plans.Communication of CAPA status and escalation to applicable stakeholders, both internal and external.Executing of Health Hazard Analysis (Product Risk Assessments)Provides oversight into the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.Provides technical expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.Supports internal and external audits and inspectionsManaging and driving audit and inspection finding investigations and resolutions with a cross-functional team.Investigates and resolves compliance problems, questions, or complaints received from other units of the company, customers, government regulatory agencies, etc.Key Skills & Experience Requires a Level 8 degree and minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience.Experience in the Medical Device Industry or a similar roleCAPA ownership/execution experience, requiredStrong understanding of medical device regulatory and governmental regulations (EU MDR, FDA, MDSAP, ISO *****, etc.)Experience in Risk Management ISO ***** Medical Device Auditing ExperienceProject Management experienceStrong analytical and problem-solving skills, excellent communication skills, excellent writing and editing skills, and computer skills in the English language.Ability to work effectively independently, within teams, and across functions.Ability to travel within Ireland and Internationally on occasion.Medtronic offer a competitive salary and flexible Benefits Package#IJA #IJPhysical Job RequirementsThe 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 & CompensationMedtronic offers a competitive Salary and flexible Benefits PackageA 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 MedtronicWe 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