Senior Quality Assurance Engineer

6 hours ago

Limerick, Limerick, Ireland beBeeQuality Full time

As a quality assurance professional, you will be responsible for ensuring that our products meet the highest standards of quality and safety. You will work closely with our operations team to identify areas for improvement and implement changes to our processes and procedures.

Job Description:

Responsibilities:

  • Work closely with operations and other business functions to ensure quality performance of products and processes
  • Approval of non-conforming items (NC), proficiency in problem-solving and root-cause activities
  • Participate in the development and improvement of manufacturing processes for existing and new products
  • Review of change management activities
  • Maintain key performance indicators (KPIs) for monitoring process quality, perform analysis and interpret trends, take action as necessary
  • Support execution and analysis of quality audits and assessments
  • Advocate human factors practices, familiarity with the science of human factor identification, reduction, and mitigation
  • Develop understanding of risk management practices and concepts, ability to become proficient in process risk
  • Develop understanding of optimization of inspection methods and sampling, support first-article inspections
  • Developing proficiency in statistical methods and application
  • Participate and interface in internal audits providing effective narrative and description of topic of expertise, participate in external audits preparation building confidence and proficiency in interactions with same
  • Assist in the development and review of process and equipment validation/qualification, build proficiency in validation processes
  • Support manufacturing transfers to other plants/facilities, execute quality activities
  • Responsible for initiation, internal containment, and support of ship and product holds for potential product escapes
Qualification Knowledge Skills:
  • Master's or Bachelor's degree in engineering or related subject
  • Previous experience in industry desirable
  • Understanding of medical device concepts desirable
  • Familiarity with ISO 13485, GDP, GMP concepts desirable
  • Excellent communication skills and attention to detail
  • Good understanding of engineering and quality concepts/theories
  • High level of PC skills, must be proficient with Microsoft Word, Excel, and PowerPoint packages
  • Self-starter with efficient work style and ability to handle multiple tasks in fast-paced environment
  • Willingness to work as part of multi-site team, with some travel required
  • Knowledge of risk-based and statistical concepts desirable
  • Problem-solving and analytical skills
  • Builds strong relationships by fostering open communications, respect, and trust, strong team player, acts with customer service/stakeholder-focused approach
  • Diplomatic, tactful, and leverages excellent interpersonal skills to help achieve outcomes
  • Accepts change openly and adopts continuous improvement orientation to the role
  • Excellent English (both oral and written)

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