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QUALITY ENGINEER

 

Company:

LOTUS TECHNICAL SERVICES
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Job Reference Number

14565291

Client ID:

RI/LTS QE C
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Posted On:

Feb 3 2012

Location:

CORK
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Job Type:

Contract

Salary:

COMPETITIVE
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Lotus Technical Services is a leading solutions provider offering a complete range of automation and technical services specifically designed to enhance productivity and efficiency, and to maximise the value of our customer's core business. We are currently recruiting a Quality Engineer based in Cork.

Job Purpose:

Reporting to the QA Technical Leader in the Innovation Centre, 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

Lotus Technical Services is an Equal Opportunities Employer