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 Of:
* Manage and drive the Corrective and Preventive Action (CAPA) Program.
o Including ownership of the investigations, Root Cause Analysis and resulting Corrective and Preventive Actions, and developing sound effectiveness check plans.
o Communication of CAPA status and escalation to applicable stakeholders, both internal and external.
o Executing 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 inspections.
o Managing 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 role.
* CAPA ownership/execution experience, required.
* Strong understanding of medical device regulatory and governmental regulations (EU MDR, FDA, MDSAP, ISO 13485, etc.).
* Experience in Risk Management ISO 14971.
* 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 & Compensation
Medtronic offers a competitive salary and flexible benefits package. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). Learn more about our business, mission, and our commitment to diversity here.
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.
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.
#J-18808-Ljbffr