Salessense

Quality Engineer-Medical Devices

IE-Galway
3 weeks ago
ID
2017-1475
# of Openings
1

Overview

Role will include co-ordinating all customer complaints, processing and controlling NCR documents, the implementation of process controls, CAPA systems, and day to day problem solving,you will also be involved in the development of quality metrics and reporting systems and will be required to conduct Internal

Qualifications

  • Min 4year industry experience in a medical device manufactuing, preferably with experience in complaints handling Science/ Engineering/Quality Degree and relevant experience
  • Previous experience within the medical device industry in Quality / Engineering is essential as is demonstrated use of Quality tools/methodologies including Six Sigma techniques
  • Experience in carrying our external and internal audits
  • Knowledge and Experience of Statistical Process Control would be beneficial
  • Excellent Computer Skills (word, excel, powerpoint and Access)
  • Excellent communication (both verbal and written) & interpersonal skills
  • Flexible, highly motivated individual and accountable

Responsibilities

  • Identify and implement effective process control systems to support the development, qualification and on going manufacturing of products to meet or exceed internal and external requirements.
  • Establish tools for monitoring and communication of quality system performance metrics on an ongoing basis and rolling up to management review.
  • Receive, co-ordinate and/or perform complaint investigation, ensure related follow-up activities and document investigation findings and results
  • Complete investigation and analysis of customer complaints
  • Drive continuous improvement initiatives and quality initiatives.
  • Ensure an efficient process is in place for the review of batch manufacturing records, process support documentation (eg NCR records) in support of product release for devices in line with supply chain
  • Direct Involvement in operations area projects and initiatives i.e Six Sigma improvements, Lean etc Develop and implement quality metrics and reporting systems.
  • Preparation of Quality reports for Quality meetings and management reviews
  • Take a lead in the implementation of process controls and CAPA systems designed to meet or exceed internal and external requirements
  • Acts as an effective team member in supporting quality disciplines, decisions and practices.
  • Apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving quality issues.
  • Ensure regulatory compliance to GMP for all medical device regulatory agencies
  • Suggest changes in procedures and standards to facilitate work efficiency and maintain quality.
  • Reporting Functional area Quality Metrics
  • Perform an active role in quality planning and new product/process introduction.
  • Conduct internal quality audits to ISO and GMP requirements.
  • Responsible for the Supplier systems including the vendor audit and internal audit programs and execute audits as required

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