Quality Engineer II - Process Validation

IE7 COV - Mallinckrodt Medical; Athlone; On-site; EUR 50,000 - 75,000; Full time

Job summary

Medtronic in Athlone is seeking a Senior Quality Engineer to provide QA and process validation input across the product lifecycle. You’ll oversee end-to-end validation activities and collaborate with cross-functional teams to ensure regulatory and quality standards are met.

The role supports new product introductions and maintenance of device safety and performance. The ideal candidate has a minimum 3+ years in medical devices, knowledge of ISO 13485, FDA QSR, and EU MDR, and practical

Qualifications

• Minimum Level 8 bachelor’s degree in Quality/Engineering/Science.
• 3+ years in medical devices or regulated environment.
• Knowledge of ISO 13485, FDA QSR, EU MDR.
• Experience with validation and quality control tools.

Responsibilities

• Provide QA and Process Validation input to the new product introduction process.
• Oversee end-to-end validation activities to ensure processes, equipment, inspections and products meet regulatory, quality, and business requirements.
• Collaborate with cross-functional teams and provide constructive feedback on quality/validation requirements.
• Author/review/approve/execute qualification/validation documents and perform statistical analysis.
• Provide on-going support during design and/or validation builds with focus on production control and reliability.

Skills

Quality Systems

Validation standards

Statistical analysis

Cross-functional teamwork

Communication skills

Education

Bachelor's degree (Level 8)

Tools

Minitab

Statistics software

Job description

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life

At our Process Validation Department in Medtronic, Athlone, we focus on providing process validation support throughout the full lifecycle of the product. From initial development of new products to ongoing support when products have been commercialized, we ensure that the performance and safety of the devices is maintained through the product lifecycle. This Senior Quality Engineer role will play a critical part in supporting new product introductions thus contributing to the global strategy and to deliver on our mission to contribute to human welfare by supporting the manufacture of products that alleviate pain, restore health, and extend life.

Responsibilities

• Provide Quality and Process Validation Engineering input to the new product introduction process.
• Overseeing end‑to‑end validation activities to ensure processes, equipment, inspections 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/validation requirements.
• Author/review/approve/execute qualification/validation documentation and perform statistical analysis to ensure products meet the required standards and specifications.
• 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.
• Understands product construction, features and uses at a competent level to contribute to the decision‑making process on product acceptance standards within their scope of responsibility.
• 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 requirements.
• Support regulatory and internal audits/inspections.
• 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.
• Provide on‑going communication, information transfer and record keeping in support of business and core‑team objectives and metrics.

Key Skills & Experience

Minimum Level 8 bachelor’s degree in a relevant Quality/Engineering/Science or related discipline. 3+ years relevant experience in a medical devices or similar regulated environment. Knowledgeable in Quality Systems, validation standards, policies, procedures and methodologies. Working Knowledge of plastic processing techniques such as Extrusion, Injection Moulding, Blow Moulding, Assembly is an advantage. Practical working knowledge of statistical data analysis and quality improvement tools and techniques is an advantage. A dynamic team‑player and problem solver who can work effectively on cross‑functional teams. Excellent organizational and time management skills and can prioritize and work effectively. Ability to multi‑task and to take initiative is essential.

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.

Pay range / Rango salarial / Intervalo salarial /Fascia retributiva / Tranche de salaire / Gehaltsband / Salaribereik: Ireland: 49,920.00 EUR - 74,880.00 EUR | This position is eligible for a short‑term incentive called the Medtronic Incentive Plan (MIP).

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. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.

This life‑changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life‑long learning These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career‑building resources you need. Life‑transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight‑driven care. Fresh viewpoints. Cutting‑edge AI, data, and automation. You’re shaping the future of healthcare technology and defining the next generation of breakthroughs in care It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here.