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Vacancy Details

Quality

Quality Engineer II - Cork

Contract Type: Permanent
Sector:
Location: Cork
Date: 1/08/2017
Job Reference: 89081

Job Description

Contact: Bimi Felix
Email: bimi@hero.ie
Telephone: 091730022

Quality Engineer II
Our client, a medical device company in Cork are currently looking to recruit a Quality Engineer II for their site.


Key Responsibilities:
  • Supervision of Quality Technicians and QC Inspectors.
  • Drive and implement process improvements to ensure predictable processes across all product lines (e.g. Risk Reduction, Yield improvements, Customer complaint reduction, Error proofing, Cost Reduction initiatives, Process Automation activities).
  • Provide effective and responsive QA support to Operations to meet their area's objectives of quality, cost and output.
  • Ensure all process variables and their interactions are adequately defined. Ensure all failure modes in process have been identified and addressed. (E.g. Use of DOE studies, FMEA's).
  • Drive and implement plant wide quality system improvements.
  • Ensure Regulatory compliance in area of responsibility to cGMP's of all medical device regulatory agencies (e.g. FDA and TUV).
  • Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles).
  • Identification and implementation of appropriate statistical techniques to monitor process performance (e.g. SPC, CpK analysis, sampling techniques).
  • Approval of change requests for product, process and quality system changes.
  • Customer complaints: Analysis of returns, approval of analysis reports and analysis of complaint trends.
  • Validation: Define process and product validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
  • Compilation of required Regulatory documentation (e.g. Technical files, Design Dossiers, Product transfer files, Essential requirements).
  • MRB: Review of MRB trends and identification of appropriate corrective actions when required.
  • Perform internal quality audits.
  • Support the implementation of Lean Manufacturing across the site.
  • Transfer and implement product and processes from development or from another manufacturing facility.
Educational Requirements:
  • Minimum of a Bachelor of Science Degree in Engineering/Technology.
  • 3/4 years' experience in a manufacturing environment or equivalent with direct experience in a QA environment (preferably GMP regulated). Experience within a Med Device/Pharma environment i.e. FDA\ISO 9000 necessary.
  • Demonstrate strong leadership skills and promote quality at source
  • Develop plans and execute on time to these plans
  • Strong Project Management skills combined with proven consistent execution within committed quality, time and cost targets.
  • Experience/training in problem solving and process improvement methodologies (Engineering Essentials TM).
For further information on this Quality Engineer II role in Cork please contact Bimi Felix on 091730022 / bimi@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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“Merit Medical have partnered with Hero for the past 10 years. During this time we have grown our employee numbers to 630 employees. Our experience of working with HERO is that they have a personal client focused approach, they know the market and they can deliver on the candidates.  The medical device market is competitive and our company success is dependent on the quality of our people, we want the best there is in the market so we can grow and in turn offer development opportunities to our people. 

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