Medtronic

Quality Engineer

Athlone, County Westmeath
ISO 13485 FDA 21 CFR 820 Agile Trackwise
Description

Quality Engineer II - 12month contract - Athlone Site

Location: Athlone, County Westmeath, Ireland

Time Type: Full time

Job Description

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

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.  The temporary Quality Engineer II will be directly involved in supporting several elements of the Quality System.

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.

  • Manage the installation, commissioning, and start-up of new sterilisation equipment.

  • Lead the validation and qualification of sterilisation equipment, including protocol development, execution, and reporting.

  • Develop and maintain equipment validation master plans and schedules.

  • Ensure ongoing compliance of all sterilisation equipment with applicable standards (e.g., ISO 11135, ISO 11137, ISO 13485, FDA 21 CFR 820).

  • Plan and execute periodic requalification and preventive maintenance activities.

  • Troubleshoot equipment issues, perform root cause analysis, and implement corrective actions.

  • Collaborate with internal teams (Quality, Manufacturing, Facilities, R&D) and external vendors.

  • Support audits and regulatory inspections related to sterilisation equipment.

  • Stay current with technological advancements and regulatory changes related to sterilisation equipment.

  • Train and mentor staff on equipment operation and validation requirements.

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

Key Skills & Experience

  • Minimum NFQ Level 8 Qualification in an Engineering, Science or Quality related discipline with a minimum of 2 years relevant experience.

  • Previous Equipment validation including Sterilization validation

  • Good knowledge of Quality and Regulatory requirements, e.g. regulatory requirements from agencies or outside professional groups (e.g. FDA, ISO etc)

  • Good compliance writing abilities with excellent attention to detail.

  • Proven problem-solving skills

  • A dynamic player and that can work effectively on cross-functional teams or independently.

  • Good communication skills

  • Knowledge of Quality related systems such as Agile, Trackwise, PQM, GCH an advantage

Medtronic offer a competitive salary and flexible Benefits Package

#INDJ 

 

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: 48,000.00 EUR - 72,000.00 EUR | 

 

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  
 

Medtronic
Medtronic

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