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SENIOR QUALITY ENGINEER

 

Company:

SIGMAR RECRUITMENT
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Job Reference Number

14566545

Client ID:

RI/SMC 23344
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Posted On:

Feb 7 2012

Location:

GALWAY
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Job Type:

Permanent

Salary:

NEGOTIABLE
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SENIOR QUALITY ENGINEER

Contract Senior Quality Engineer required by Galway Medical Device manufacturer. Degree or Diploma in Mechanical, Electrical, Manufacturing Engineering or equivalent is required. At least 5 years industrial experience in a Manufacturing or Quality Engineering related role.

Duties:

  • Provide Quality Engineering support to various departments including R&D, Quality and Engineering.
  • Provide quality engineering support for new product development, including the efficient and timely transfer of Quality systems knowledge from advanced quality engineers and coordination the training of relevant personnel on new quality systems and equipment.
  • Ensure all appropriate documentation is in place prior to production start.
  • Ensure Quality System compliance with world-wide regulatory requirements (ISO13485, FDA, QSRs)
  • Assist customers in resolving product issues including customer complaints.
  • Support supplier management in Material Quality, Certification and Validation activities. Drive improvement by assuring adequacy in the vendor's quality programs & inspection methods and shall participate in key processes which include: Material Review Board, Supplier Audits, and issuance of Supplier Corrective Action Requests.
  • Drive continuous Quality Improvement within the Business Units by assuring adequacy in the quality programs & inspection methods and shall participate in key activities which include: Material Review Board, Internal Audits and
  • implementation of corrective and preventative action.
  • Lead Problem Solving, Failure Analysis, Corrective Action & Preventative Action activities within the Team
  • Implement SPC techniques where appropriate.
  • Develop and implement Inspection Monitoring and Process Control procedures.
  • Lead Process Validation activities within the Team
  • Work within the business unit cross functional team to continuously improve its achievement of business goals
  • Provide training in Quality Processes & Techniques to the extended team
  • Has the authority to order the cessation of activities in relation to production, process validation and new product introduction. Also has the authority to order recommencement of these activities provided he/she is satisfied that all issues affecting product safety and efficacy have been addressed