Senior Quality Systems Engineer

1 day ago

Galway, Ireland Medtronic Full time

Join to apply for theSenior Quality Systems Engineerrole atMedtronic.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.ResponsibilitiesManage and drive the Corrective and Preventive Action (CAPA) Program, including ownership of investigations, root cause analysis and resulting corrective actions, and developing sound effectiveness check plans.Communicate CAPA status and escalation to applicable stakeholders, both internal and external.Execute Health Hazard Analysis (Product Risk Assessments).Provide 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.Provide technical expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.Support internal and external audits and inspections, managing and driving audit and inspection finding investigations and resolutions with a cross-functional team.Investigate and resolve compliance problems, questions, or complaints received from other units of the company, customers, government regulatory agencies, etc.QualificationsRequires 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 role.CAPA ownership/execution experience, required.Strong understanding of medical device regulatory and governmental regulations (EU MDR, FDA, MDSAP, ISO *****, etc.).Experience in Risk Management ISO *****.Medical Device Auditing Experience.Project Management experience.Strong 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.Key Skills & ExperienceCAPA ownership/execution experience, required.Strong understanding of medical device regulatory and governmental regulations (EU MDR, FDA, MDSAP, ISO *****, etc.).Experience in Risk Management ISO *****.Medical Device Auditing Experience.Project Management experience.Strong 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.Benefits & CompensationMedtronic offers a competitive salary and flexible benefits package, including a short-term incentive called the Medtronic Incentive Plan (MIP).You will receive a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.Location: Galway, County Galway, Ireland.#J-*****-Ljbffr

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