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Quality Engineer - Medical Device

Job Seekers Ireland Engineering, Science Life Science, Manufacturing

Job Summary

  • Cork
  • Permanent
  • BBBH763253
  • Jul 22, 2020
  • Competitive
Job Description

Leading Medical Device company in search of an Experienced Quality Engineer to join their their team

If you are looking for a company with a global reach that can offer you excellent career opportunities and personal development along with a local collaborative team then keep reading.

I am working with a Global leader in the Medical device landscape who are looking for an experienced Quality Engineer to join their team. This individual will provide expert QA support to Operations, in ensuring operational goals and objectives are achieved for the site.

Key Responsibilities:

  • Supervision of Quality Technicians and QC Inspectors.
  • Be the SME regarding Acceptable Quality Standards for products and processes.
  • Establish and encourage interdepartmental relationships and collaboration.
  • Drive and implement process improvements to ensure predictable processes across all areas of the Materials Management area
  • Provide effective and responsive QA support to Operations to meet their area's objectives of quality, cost and output.
  • 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
  • Identification and implementation of appropriate statistical techniques to monitor process performance
  • Approval of change requests for product, process and quality system changes.
  • Validation: Define process and product validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
  • 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.

Requirements:

  • 2-5 years' experience in Manufacturing or Quality with a Level 8 qualification in Engineering or related technical/Quality discipline.
  • Excellent written and verbal communication skills
  • Demonstrated ability to work with cross functional organizations in a dynamic manufacturing environment to solve problems
  • Strong command of MS Office - Word, Excel, PowerPoint.
  • Ability to rapidly learn and use new applications

Perferred Qualifications:

  • Previous experience in a Quality, or Manufacturing background, particularly in relation to incoming inspection
  • Experience in the Medical Device industry and working knowledge and understanding of FDA and ISO13485
  • Lead auditor certification ISO 13485 or previous auditing experience.
  • Experience in problem solving and process improvement methodologies
  • Process Validation, Risk Management, CAPA experience.

If this sounds of interest, or if you would like to hear more then click the 'Apply Now' button below or reach out to Kellie on kodonovan@morganmckinley.com or 021 2300 300.

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.

Consultant Details

Consultant Details

kellie-o-donovan
Kellie O'Donovan
  • Consultant | Engineering Recruitment - Quality & Validation
  • 353 (0) 21 2300300
  • kodonovan@morganmckinley.com