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Operations Team Leader – Plant 2

January 1, 2017 Comments (0) Views: 154 Opportunities

Quality Engineer

Ready for a quality move? Interested in partnering with key customers to turn new projects into real life manufacturing solutions? Then, we may have the role for you!

Mergon International, Castlepollard, Westmeath, Ireland

Mergon Group is a leading supplier of innovative plastic products to world class customers in the automotive, industrial and healthcare sectors. The Group has manufacturing operations in Ireland, the US and the Czech Republic.

At Mergon International Castlepollard, we want to recruit a Quality Engineer to join our healthcare quality team.

The Role

Reporting to the Quality Manager, as Quality Engineer, you will be responsible for for maintaining product quality and related documentation in accordance with the ISO13485 and ISO9001 requirements.

Key Responsibilities

  • Implement and maintain the quality system to the international standard ISO 13485 and all applicable regulations under the Medical Device Directives.
  • Overall responsibility for Documentation Control.
  • Evaluate and improve quality systems within the international standard ISO13485 and ISO9001 including CAPA, Internal Audit, External Audit, Vendor Control, Documentation Control and Change Control.
  • Complete Product and Process risk assessments under ISO 14971.
  • Responsibility for investigations into Product/Process non-conformances and customer complaints on both Medical and non-medical products.
  • Perform an active role in quality planning and new product introduction to the healthcare division.
  • Lead cross functional teams in continuous improvement activities, championing a structured approach to problem solving.
  • Provide training in Quality Processes and Procedures to the extended production and technical support team.
  • Maintain the training database and ensure all personnel are trained to the current revisions of all relevant quality documentation.
  • Maintenance of the calibration system.

 

Key Relationships

Quality Assurance Team: Work Closely with the Quality Team, providing support in other areas where required.

Customers: Good communication written and verbal to build excellent relationships with customers through frequent contact and visits when required, along with dealing with customer complaints.

Production: Liaise on Quality Issues.

Product Development Department: Be involved from the beginning on new projects ensuring that there is a focus on quality from the beginning.

 

Contract Duration

1 Year Full-Time Contract.

 

The Candidate

The successful candidate will:

  • Have a relevant 3rd level qualification with 3+ years quality experience post-graduation.
  • Experience with ISO13485, ISO9001 and TS regulations an advantage.
  • Experience in moulding environment (injection or blow moulding) preferred.
  • Experience in driving continuous improvement projects.
  • The ability to blend best practices from different methodologies to deliver results (Six Sigma, Lean, Kaizen).
  • Demonstrated methodical and analytical approach.
  • Strong attention to detail with structured approach to planning & organising.
  • Be able to work on own initiative and priorities work as required.
  • Have excellent communication skills.

Applicants should forward a cover letter and CV to hr@mergon.com.


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