Senior Quality Engineer - Process Validation

IE7 COV - Mallinckrodt Medical; Athlone; On-site; EUR 65,000 - 97,000; Full time

Benefits offered by this job

Competitive salary

Flexible benefits

Incentive plan

Job summary

Medtronic is seeking a Senior Quality Engineer in Athlone, Ireland to lead end-to-end validation across the product lifecycle. You will collaborate with cross-functional teams, develop device validation strategy, and provide QE leadership to ensure ISO 13485, FDA QSR, EU MDR compliance while supporting audits and continuous improvement.

The role requires a minimum 8 Level bachelor’s degree in engineering or science and 5–7 years in Quality or Medical Devices with strong data analysis and

Qualifications

• Must have a minimum Level 8 bachelor’s degree in engineering or science with 5–7 years of experience in Quality or Medical Devices.
• Demonstrated expertise in IQ/OQ/PQ, risk management, and equipment and validation lifecycle management.
• Experience with statistical data analysis, problem solving and quality improvement tools.

Responsibilities

• Lead end-to-end validation activities to ensure processes, equipment, inspections and products meet regulatory, quality, and business requirements throughout the product lifecycle.
• Collaborate with cross-functional teams; develop strong partner relationships and provide quality leadership.
• Develop device process validation strategy and provide expert QE direction for equipment qualification and validation activities.
• Provide online support during design/validation builds focusing on production control, product evaluation, and reliability.
• Author and support qualification/validation plans and reports, performing statistical analysis to meet standards.

Skills

IQ/OQ/PQ

Statistical analysis

Problem solving

Quality engineering

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in engineering or science

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

• Leading and 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 leadership.
• Develop device process validation strategy and provide expert QE technical direction/input to equipment qualification and validation activities.
• 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 plans and reports, performing statistical analysis to ensure products meet the required standards and specifications.
• 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 requirements.
• Support regulatory and internal audits/inspections by providing validation expertise and documentation.
• Mentor junior engineers and contribute to continuous improvement of validation standards and best practices.
• 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 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. Ability to multi‑task and to take initiative is essential. Strong interpersonal, communication and organizational skills. Excellent documentation, communication, and cross‑functional collaboration skills.

Benefits & Compensation

• Medtronic offers a competitive salary and flexible Benefits Package
• Pay range / Rango salarial / Intervalo salarial /Fascia retributiva / Tranche de salaire / Gehaltsband / Salaribereik: Ireland: 64,640.00 EUR - 96,960.00 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 settingis 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.

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.