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

In our Customer Quality Experience Management (CQXM) Returned Product Analysis (RPA) Lab, which is part of the Galway CQXM Complaint Handling and Regulatory Reporting Department in Medtronic, we focus on complaint handling and post market regulatory reporting activities for a wide range of Medtronic products. You will be part of a high performing Complaint Handling department, which provides value throughout the Product Life cycle through world class execution in Medical Device Reporting and Vigilance compliance. The RPA lab focus is on the Returned Product Analysis and complaint investigation.

• Ability to work within a team environment and build relationships across the organisation as well as with external suppliers & regulatory agencies etc.
• Co-ordination of complaint handling Analysis and Investigation activities for a wide range of Medtronic products including receipt and documenting of incoming complaint devices relating to events.
• Perform analysis and investigation, and laboratory duties related to the complaint Analysis and Investigation activities. Assisting in test procedure development and non-routine analyses relating to root cause investigations.
• Co-ordination of cross-functional activities in the investigation of customer complaints and determination of root cause.
• Possess an awareness of the manufacturing process and final products, including terminology associated with the product use and failure modes typically experienced by the customer
• Conduct laboratory support functions, Performs and coordinate instrument maintenance, calibration and alignment checks.
• Communicate key information including escalation of Quality Issues to the CQXM Management and key extended post market quality teams & functional management to ensure full engagement &alignment.
• Contribute to continuous improvement activities to support the role out of cell operating systems and principles within the CQXM department. Delivering cost-down through innovative solutions.
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• Support new product launch as part of the Product Development Process ensuring that CQXM requirements are included in the process.
• Ensure compliance to all applicable department, site-wide procedures and regulations. Support Internal and External audit preparation and activity which includes application and maintenance of quality standards for all activities associated.
• Train and support new analysts.

Key Skills & Experience
• Level 8 Bachelor’s degree in Engineering, Science or technical field with 4+ years of experience in Quality or Medical Devices or Advanced degree in Engineering, Science or technical field with 2+ years of experience in Quality and/or Engineering.
• You are technically orientated with a strong risk-based approach to problem solving.
• You can work independently under limited supervision to determine and develop this best approach.
• You are a dynamic team player and leader and can work effectively and proactively on cross-functional teams with a high level of enthusiasm and motivation.
• Strong communication, organizational, presentation and leadership skills are desirable.
• Excellent problem-solving skills are desirable.
• Experience with Agile, SAP and GCH an advantage.
• You are a good communicator and fluent in English, both verbal and written.

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 CQXM RPA Lab Department, in Medtronic, plc, we focus on supporting complaint handling activities, returned product analysis and complaint Investigation for a wide range of Medtronic products to ensure that customer and patient needs are met every day. Our key focus is on delivering and maintaining a high level of Quality to ensure that business and performance goals are achieved. The Quality Engineer role is critical in supporting key department metrics thus contributing to the global strategy and to deliver on our mission to contribute to human welfare by supporting the post-market activities of products that alleviate pain, restore health, and extend life.

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:

• Ability to work within a team environment and build relationships across the organisation as well as with external suppliers & regulatory agencies etc.

• Oversee laboratory duties related to the complaint Analysis and Investigation activities, including receipt, decontamination and documenting of incoming complaint devices relating to events.

• Coordination of cross-functional activities in the investigation of customer complaints and determination of root cause.

• Communicate key information including escalation of Quality Issues to the CQXM Management and key extended post market quality teams & functional management to ensure full engagement & alignment.

• Develops, modifies, applies and maintains quality standards and protocols to support new product launch or lab transfer as part of the Product Development Process ensuring that CQXM requirements are included in the process.

• Designs or specifies inspection and testing mechanisms and equipment. Performs and coordinate instrument maintenance, calibration and checks.

• Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements.

• Participate in preparing / critically reviewing/approving CAPAs/ Investigations and validation activities, providing expert technical direction and solutions as appropriate.

• Develop training plan for increase versatility and onboarding of new analysts.

• Ensure compliance to all applicable department, site-wide and enterprise procedures, and regulations.

• Support Internal and External audit preparation and activity which includes application and maintenance of quality standards for all activities associated.

Key Skills & Experience

• Level 8 Bachelor’s degree in Engineering / Science or related discipline and minimum 2 years’ relevant experience.

• You are a dynamic team player and leader and can work effectively and proactively on cross-functional teams with a high level of enthusiasm and motivation.

• Good communication, organizational, presentation and leadership skills are desirable.

• Excellent problem-solving skills are desirable.

• Manufacturing process and product knowledge, design, post-market or Complaints experience is an advantage.

• You are a good communicator and fluent in English, both verbal and written.

Medtronic offer a competitive salary and flexible Benefits Package

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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 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 here