Quality Assurance Engineer Leader

2 weeks ago

Cork, Cork, Ireland beBeeEngineering Full time €66,000 - €90,000

As a Quality Assurance Engineer Leader, you will play a key role in ensuring the quality of our products and processes.

You will work closely with operations and business functions to guarantee the performance of our products and processes. Collaborate with cross-functional teams and suppliers to address top-quality issues, own identified internal and supplier non-conformances, and manage timely closure of NC's. Own or support identified internal CAPAs, manage timely root cause investigation, implementation, and closure.

You will communicate and collaborate with suppliers regarding non-conformances, escalate supplier corrective actions as required, engage in the development and improvement of internal manufacturing processes for existing products, perform critical assessment of internal and supplier proposed change management activities, and participate in the creation and/or review of new or modified procedures.

  • Experience in interacting with regulatory agencies desired
  • Understanding of US and International Medical Device Regulations
  • Familiarity with ISO 13485, GDP, GMP required
  • Strong knowledge of Quality concepts (e.g. Risk Management, CAPA, Audits, Statistics)
  • Must possess strong communication, project management, and influencing skills as well as have the ability to manage multiple tasks simultaneously
  • Ability to represent Quality function within and across the project teams
  • Strong interpersonal skills, written, oral communication, and negotiation skills
  • Strong in critical thinking and outside-the-box thinking
  • Highly developed problem-solving skills,
  • Strong analytical skills
  • Demonstrated ability to successfully manage and complete projects in a matrix organisation
  • Demonstrated ability to work independently and as part of cross-functional teams
  • Experience in working in a compliance risk situation
  • Previous industry experience required
  • Computer literacy

We are looking for a Quality Assurance Engineer Leader who can drive continuous improvement actions to reduce manufacturing defects and provide leadership and subject matter expertise in QA activities to the overall site.

Key Qualifications:
  • BS in a science, engineering, or related discipline
  • MS, CQE, or CRE preferred.
  • Six Sigma Green or Black belt preferred.
  • Minimum of 4 years' experience preferred

This is a full-time opportunity for a motivated and experienced Quality Assurance Engineer Leader to join our team.

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