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Vacancy Details

Quality

Quality Engineering Leader - Cork

Contract Type: Permanent
Sector:
Location: Cork
Date: 1/07/2017
Job Reference: 83554

Job Description

Contact: Cliona O'Malley
Email: cliona@hero.ie
Telephone: 091730022

Quality Engineering Leader
Our client, a global leader in the Medical Device industry, are looking to recruit a Quality Engineering Leader for their Cork plant on a permanent basis.

Key Responsibilities:
  • Support quality improvement initiatives
  • Review/analyse the effectiveness of Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
  • Supports the development of quality engineering, quality compliance, quality leadership talents with the right skill sets for new product introductions, and product life cycle management.
  • Review/analyse whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.
  • Provides supervision, mentoring, coaching, performance review, developmental plans, and succession planning for others (including Quality Engineers and Technicians)
  • Lead/provide guidance to the Line Quality team on areas such as Conducting investigations, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
  • Approve IQ, OQ, PQ, TMV or Software Validation
  • Document, justify, review or analyse whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs
  • Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.


Education, Experience and Skills:
  • Bachelor Degree, preferably in Engineering or a related technical field.
  • 5-8 years' industrial experience, of which 3+ years in a team leading role
  • Experience working a regulated environment is required. Such experience within a FDA / ISO 13485 regulated environment would be preferred
  • Demonstrated ability to successfully use, and coach others in the use of, recognized data analysis and problem solving methodologies is required (e.g. DMAIC, Six Sigma, etc.)
  • Strong coaching, mentoring and team development skills are required
  • Technical training and experience in using Statistical Techniques, Lean and/or Six Sigma methodologies is preferred (e.g. SPC, DOE, Reliability Analysis, etc.)

For further information on this Quality Engineering Leader please contact Cliona O'Malley on 091730022 / cliona@hero.ie
Check out all our open jobs on our HERO Recruitment website - www.hero.ie

Please Note: HERO Recruitment will not forward your details to any company without your prior approval


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Adrian Rice,
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Boston Scientific

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Hollister ULC, Ballina, Co. Mayo

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Mary Collins,
Senior Director, Human Resources Europe
Merit Medical

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Boston Scientific 

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