Senior Quality Engineer – Galway – Perm

  • Reference: GY45893
  • Job Type: Permanent
  • Location: Galway
  • Category: Engineering, Technical & Manufacturing

As Senior Quality Engineer you will provide a support role to the Quality Manager in the routine maintenance of my client’s Quality Management Systems and in Quality related projects. The Senior Quality Engineer reports to the QA & RA Manager.

 

Responsibilities:

  • Possesses and applies comprehensive knowledge of Quality, and its application to the completion of complex assignments.
  • Advanced knowledge of the organization’s operations and practices to enable informed decisions, and providing direction to Quality team and other functional areas.
  • Responsibility for delivery of projects originated in QA or participate within Core Team for Quality deliverables of business wide projects.   
  • Identifies key barriers/core problems and applies problem-solving skills in order to deal creatively with complex situations. Troubleshoots and resolves complex problems with effective solutions.
  • Makes decisions under conditions of uncertainty, sometimes with incomplete information, that produce effective end results.  Applies risk assessment techniques in such circumstances. 
  • Independently performs assignments with instruction limited to results expected.  Determines and develops approach to solutions.
  • Drives business improvements through mentoring and support for the continuous improvement initiatives.
    • Escalation point for quality related non-conformances and CAPAs.
    • Drives compliance cross functionally in alignment with the regional objective for collaboration and multi-site ISO13485 certification. 

 

Qualifications & Skills and Experiencce:

  • Third level qualification.
  • Minimum 5 years of experience in medical device industry with minimum 3 year of progressively responsible positions, including;
    • competent working knowledge of recognized Quality Management Systems (e.g. ISO9001/ ISO13485/ ISO14971/ GMP),
    • awareness of relevant laws and regulations (e.g. CE/ FDA/ PAL)
    • Broad knowledge of engineering and technical applications applied in development of medical devices useful.
  • Excellent interpersonal, written and verbal communication skills, including ability to make clear, well founded decisions regarding conformity during audits.
  • Pro-active attitude, excellent organization skills, and ability to manage multiple projects while delivering results on time.
  • Proficient with MS Word, Excel, Power Point, and management of spreadsheets.

For a confidential discussion and more information on the role/company please  email your CV to: amy.oneill@collinsmcnicholas.ie


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Amy O’Neill

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  • Amy O’Neill
  • Recruitment Consultant
  • 091706718
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