Quality Assurance Lead

2 weeks ago

Cork, Cork, Ireland beBeeQuality Full time €55,000 - €75,000
Job Overview

This is a 23 month fixed term contract based in Cork.

About the Role

We are seeking a Quality Assurance Lead to provide quality engineering support in quality assurance, control, and preventative activities with a focus on continuous improvement of internal products and processes.

Key Responsibilities
  • Provide quality engineering support in quality assurance, control, and preventative activities with a focus on continuous improvement of internal products and processes.
  • Support supplier quality issues impacting daily operations.
  • Advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers.
  • Mentor and provide technical direction across multiple areas of expertise.
  • Ensure compliance to regulation and standards.
Requirements
  • Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) 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.
  • Some travel may be required.
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.

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