Job Reference 14144
Job type Permanent
Location Athlone
Salary € 60,000+

The Role

Senior Quality Engineer

Location: Athlone

Permanent

Salary: €60k - €65k plus benefits

Standard working hours - 8:30am - 5:30pm Monday to Thursday, 8:30am - 1:30pm Friday

  • Ensures major nonconformance’s and trends are escalated to management and prioritized commensurate with risk.
  • Identifies and effectively issues SCARs where quality issues are identified in relation to product received from suppliers.
  • Supports the completion of risk assessment and validations as applicable.
  • Conducts device evaluations related to product issues and performance.
  • Communicates with stakeholders globally to ensure alignment, resolve problems, and share best practices.
  • Leads major issues, when appropriate.
  • Facilitates external regulatory and customer audits.
  • Lead & drive programs and projects that deliver ‘best in class’ manufacturing metrics.
  • Change control
  • Monitor and control progress of supplier quality projects, ensure sound application of engineering, provide project reviews where necessary.
  • Will abide to Environmental, Health and Safety (EHS) Policies and any relevant other EHS documentation.
  • Will comply with all relevant training required and adhere to relevant associated documentation.
  • Follow strict adherence to the requirements of CGMP.
  • Actively contribute to the enhancement of compliance initiatives for areas of responsibility.

The Person

Education:
  • Qualification in Quality, Science or Engineering, and/or relevant experience.
Experience:
  • Five (5+) years experience in a Medical Device environment.
Skills:
  • Good working knowledge of Statistical techniques and methods.
  • Problem solving skills for developing creative solutions and meeting objectives are required.
  • Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook and Excel)
  • Working knowledge of Oracle/SAP/ERP system and Business Objects software program.
  • Excellent analytical ability
  • Ability to work well under deadlines and pressure
  • Communication skills
  • The ability to prioritize tasks and be able to manage several projects and tasks simultaneously; and the ability to interface with all levels of management.
  • Proven leadership skills in Quality Systems & Regulatory

Apply Now






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