At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.

A Day in the Life

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 Quality Department in Medtronic Athlone we focus on providing compliance solutions and documentation throughout the product lifecycle designed to continuously improve our manufacturing processes systems quality and regulatory compliance to the highest standard. We are seeking a Senior Quality Engineer with a strong focus on validation activities to support new product introductions process changes and ongoing manufacturing operations in a regulated environment.

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.

• The Senior Quality Engineer (Validation) is responsible for leading and overseeing endtoend validation activities to ensure processes equipment and products meet regulatory quality and business requirements throughout the product lifecycle.

• Function effectively as part of cross functional teams; develop strong partnering relationships within these groups collaborate and provide constructive feedback and quality leadership

• Provide online support during design and/or validation builds with emphasis on production control product evaluation and reliability inventory control and/or research and development as they apply to product or process quality

• Author and support qualification/validation protocols and reports performing statistical analysis to ensure products meet the required standards and specifications

• Support root cause investigations; drive problem solving efforts for quality issues. Ensure that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements

• Understands product construction features and uses at a highly competent level to contribute to the decision-making process on product acceptance standards within their scope of responsibility.

• Devises and implements methods and procedures for inspecting testing and evaluating the precision and accuracy of products and production equipment.

• Complete test method validation for methods and procedures used for inspecting testing and evaluating the precision and accuracy of products test and production equipment

• Ensure validation activities align with ISO 13485 FDA QSR EU MDR and internal quality systems.

• Support audits and inspections by providing validation expertise and documentation.

• Mentor junior engineers and contribute to continuous improvement of validation standards and best practices.

Key Skills & Experience

• Minimum NFQ Level 8 bachelors degree in Engineering or Science and desirably with 5-7 years of experience in Quality or Medical Devices

• Significant experience in a Quality Engineering role with a strong validation focus ideally in medical devices or another highly regulated industry.

• Demonstrated expertise in IQ/OQ/PQ risk management and equipment and validation lifecycle management.

• Practical working knowledge of statistical data analysis problem solving and quality improvement tools and techniques preferable

• Ability to multi-task and to take initiative is essential

• Strong interpersonal communication and organizational skills

• Excellent documentation communication and crossfunctional collaboration skills.

Medtronic offer a competitive salary and flexible Benefits Package

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 95000 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