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Quality Engineer

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Abbott Laboratories

3d ago

  • Job
    Full-time
    Junior, Mid & Senior Level
  • Engineering
  • Galway

AI generated summary

  • You need a relevant degree, experience in medical devices/pharma, knowledge of quality systems and regulations, strong communication skills, organizational ability, and proficiency in MS Office.
  • You will ensure compliance with quality processes, address non-conformances, analyze data, drive improvements, and make informed decisions while collaborating with internal and external associates.

Requirements

  • Third level qualification in a relevant Science/Engineering discipline
  • Relevant experience in the medical device/pharma industry
  • Competent working knowledge of recognized Quality Management Systems (e.g. ISO9001/ ISO13485/ ISO14971/ GMP), awareness of relevant laws and regulations (e.g. CE/ FDA/ PAL)
  • Broad knowledge of engineering and technical applications applied in development of medical devices useful
  • Excellent interpersonal, written and verbal communication skills, including ability to make clear well founded decisions regarding conformity during audits
  • Pro-active attitude, excellent organization skills, and ability to manage multiple projects while delivering results on time
  • Proficient with MS Word, Excel, Power Point, and management of spreadsheets

Responsibilities

  • Carries out duties in compliance with established business policies and procedures.
  • Demonstrates commitment to the development, implementation and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies.
  • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
  • Responsibility to understand and maintain awareness of the quality consequences which may occur from the improper performance of their specific job.
  • Perform other duties and projects as assigned.
  • Possesses and applies a broad and increasing knowledge of Quality, and its application within Abbott, to the completion of moderately complex assignments.
  • Broad knowledge of Abbott’s organization’s operations and practices to enable informed decisions in day to day operations and assignments.
  • Applies problem-solving skills in order to deal creatively with complex situations, work that typically requires processing and interpreting, more complex, less clearly-defined issues. Identifies problems and possible solutions and takes appropriate action to resolve. Demonstrates skill in data analysis techniques by resolving missing/ incomplete information.
  • Seeks consensus for decisions under conditions of uncertainty, sometimes with incomplete information, in order to produce effective end results. Applies risk assessment techniques in such circumstances.
  • Drives business improvements through continuous improvement initiatives.
  • Escalation point for quality related non-conformances and CAPAs.

FAQs

What is the purpose of the Quality Engineer position?

The Quality Engineer provides support to the Quality Manager in maintaining the Quality Management Systems at Rapid Diagnostics International Limited (RDIL) and handling moderately complex Quality related projects.

What qualifications do I need to apply for the Quality Engineer position?

A third level qualification in a relevant Science or Engineering discipline is required to apply for the Quality Engineer position.

Is this a permanent position?

No, this position is initially a 1-year fixed-term contract.

What industries should my experience be in?

Relevant experience in the medical device or pharmaceutical industry is required for this position.

What regulatory standards should the Quality Engineer be familiar with?

The Quality Engineer should have a competent working knowledge of recognized Quality Management Systems such as ISO9001, ISO13485, ISO14971, and GMP, as well as awareness of relevant laws and regulations like CE, FDA, and PAL.

What skills are necessary for this role?

The role requires excellent interpersonal, written, and verbal communication skills, a pro-active attitude, excellent organization skills, and the ability to manage multiple projects while delivering results on time.

What types of projects will the Quality Engineer handle?

The Quality Engineer will handle moderately complex Quality related projects as well as participate in continuous improvement initiatives and address quality-related non-conformances and CAPAs.

What software skills are expected for this position?

Proficiency with MS Word, Excel, and PowerPoint, along with management of spreadsheets, is expected for this position.

Will the Quality Engineer interact with external business associates?

Yes, the Quality Engineer is responsible for exhibiting professional behavior with both internal and external business associates.

What is the expected commitment to Quality Processes?

The Quality Engineer is expected to demonstrate commitment to the development, implementation, and effectiveness of applicable Quality Processes in compliance with ISO, FDA, and other regulatory agencies.

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Abbott Laboratories

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

At Abbott, we’re dedicated to helping people live more fully, in everything we do. We’re creating the future of healthcare through life-changing technologies that make you healthier and stronger, quickly identify when you have a medical need, and treat conditions to help you get back to doing what you love. With headquarters in north suburban Chicago, Abbott serves people in more than 160 countries with leading medical devices, diagnostics, nutrition products and branded generic medicines. More than 115,000 of us are helping millions of people to live better and healthier, every day around the world. Our employees do work that matters as part of a global community that supports them with career development opportunities and locally competitive benefits. Mission: We help people live better and healthier with our life-changing technologies. We're revolutionizing health with the most personal technologies, empowering people with the data and knowledge they need to help them live longer and better.