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QUALITY ENGINEER - CORK
Company:ICDS RECRUITMENT |
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Job Reference Number |
14572016 |
Client ID: |
RI/AM12481 |
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Posted On: |
Feb 22 2012 |
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Location: |
CORK |
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Job Type: |
Contract |
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Salary: |
NEGOTIABLE |
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This is a 12 month contract .
Job Purpose:
Reporting to the QA Technical Leader, the Quality Engineer shall lead from a Technology and Product Inspection perspective related to all Strategic Inspection/Compliance activities. You will be working with the Quality, Operations and R&D functions throughout the company.
Responsibilities:
• Produce and maintain appropriate and comprehensive quality process specifications as required during the development and implementation of new technologies/processes.
• Lead and manage inspection strategy for the site and maintain detailed project plans to be an effective program manager.
• Document and maintain in good order all relevant Quality assurance Design Controls as directed by Data Management.
• Compile and execute validation protocols for new technologies. Ensure correct implementation as per standard validation procedures. Re-validate as required due to engineering change, deviation analysis or upgrade in systems and material. Prepare documentation to support any regulatory submissions as a result of implementation of new technologies / inspection methods.
• Generate URS for new technology / equipment as a part of the Asset Life Cycle.
• Develop and utilise DFMEA/PFMEA and other QA risk analysis techniques
• Lead overall inspection strategy for inspection/compliance activities for all new products to ensure latest technology is available to reduce Human Error.
• Lead QA input in Design for Manufacture activities on site related to inspection.
• Ensure compliance with all Documented Quality systems, as per SEP 180 i.e. FDA QSR’s and ISO 13485/9001 requirements etc. during day to day and assigned audit/CAPA activities
• Provide technical assistance to carry out problem analysis/complaint investigation related to product inspection and data analysis.
• Review and approve gauge, tooling, fixturing drawings, and CMM programs to ensure compliance to product specifications.
• Maintain a good level of house keeping in designated areas, and observe all Health and Safety at work requirements.
• To operate within the company’s standard operating procedures and review, maintain and create appropriate procedures for sphere of activity.
Requirements:
• A diploma/degree level or similar qualification in a Science related discipline with proven experience in manufacturing processes and business metrics and a minimum of 5 years experience in a technical role
• Proven knowledge and ability regarding equipment and process validations within a regulated industry and the ability to create and deliver functional / site strategies
• Proven knowledge and ability of FDA and MDD GMP requirements regarding medical Devices and ability to work and identify key suppliers for all KPI’s such as RFQ’s, URS, On-time delivery, and service agreements.
• Experience within Process Excellence through Green Belt/Black Belt Training
