Chief Quality Engineer

6 days ago

Limerick, Limerick, Ireland beBeeQualityEngineer Full time €60,000 - €80,000
Job Overview

This position is responsible for delivering quality engineering support in quality assurance, control and preventative activities within operations and other business functions.

The successful candidate will have a focus on preventative measures and continuous improvement of products and processes.

  • They will work closely with operations and the business functions to ensure quality performance of product and processes.
  • Approval of Non-Conformance Reports and proficiency in problem solving and root causing activities are key requirements.
  • The role involves participating in the development and improvement of the manufacturing processes for existing and new products.
  • Change management activities will also be reviewed.
  • Maintaining Key Performance Indicators (KPIs) for monitoring of process quality, performing analysis and interpreting trends, taking action as necessary is essential.
  • Supporting execution and analysis of Quality Assurance Testing (QATs) is also required.
  • A strong understanding of Human Factor practices and concepts, including identification, reduction and mitigation, is needed.
  • Developing an understanding of risk management practices and concepts, with the ability to become proficient in process risk is essential.
  • The role also involves developing an understanding of optimization of inspection methods and sampling, supporting First Article Inspections.
  • Proficiency in statistical methods and application is also a requirement.
  • Participating and interfacing in internal audits, providing effective narrative and description of topic of expertise, and participating in external audits preparation, building confidence and proficiency in interactions with same is required.
  • Assisting in the development and review of process and equipment validation/qualification, building proficiency in validation processes is essential.
  • Supporting manufacturing transfers to other plants/facilities, executing quality activities is also required.
  • Responsibility for initiation, internal containment and support of ship and product holds for potential product escapes is also part of this role.
Required Skills and Qualifications
  • Bachelor's or Master's degree in Engineering or related subject.
  • Previous experience in industry is desirable.
  • Understanding of Medical Device concepts is also desirable.
  • Familiarity with ISO 13485, GDP, GMP concepts is desirable.
  • Excellent communication skills and attention to detail are essential.
  • Good understanding of engineering and quality concepts/theories is required.
  • High level of PC skills, proficiency with Microsoft Word, Excel and PowerPoint packages is also required.
  • Self-starter with efficient work style and ability to handle multiple tasks in fast-paced environment is essential.
  • Willingness to work as part of multi-site team, with some travel required is also a requirement.
  • Knowledge of Risk Based and statistical concepts is desirable.
  • Problem solving and analytical skills are essential.
  • Building strong relationships by fostering open communications, respect and trust, strong team player and acts with customer service/stakeholder focused approach is required.
  • Diplomatic, tactful and leverages excellent interpersonal keys to help achieve outcomes.
  • Able to accept change openly and adopts a continuous improvement orientation to the role.
  • Excellent English (both oral and written) is required.
  • Able to be voice of Quality when dealing cross functionally.

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