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AMBITIOUS QUALITY ENGINEER REQUIRED
Company:LOTUS TECHNICAL SERVICES |
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Job Reference Number |
14565262 |
Client ID: |
RI/LTS QE C |
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Posted On: |
Feb 3 2012 |
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Location: |
CORK |
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Job Type: |
Contract |
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Salary: |
COMPETITIVE |
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We currently have a Quality Engineer position based in Cork. This is an ideal position for an experienced Engineer who is seeking to work in an ambitious and fast-paced environment.
Responsibilities:
· Produce and maintain appropriate and comprehensive quality process specifications as required during the development and implementation of new technologies/processes.
· Continuous Improvement Focus Introduce new technologies in parallel for new product introductions and current processes to ensure compliance to all regulations/specifications.
· 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. Lead knowledge sharing between facilities from a QA/Inspection perspective.
· Develop and utilise DFMEA/PFMEA and other QA risk analysis techniques in order to minimise potential risks during development/implementation activity.
· 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.
Skills, Experience & Qualifications:
· Degree Qualified with 3-5 years relevant industrial experience preferably in Medical Devices/Pharmaceutical Industry
· Ability to learn and understand complex processes by investigation and being able to in-return simplify and present a solution
· Proven Experience relating to FMEAs Proven knowledge and ability regarding equipment and process validations within a regulated industry.
Lotus Technical Services is an Equal Opportunities Employer
