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QUALITY ENGINEER
Company:CBS BUTLER |
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Job Reference Number |
13512468 |
Client ID: |
RI/RWA45678 |
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Posted On: |
Jun 26 2009 |
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Location: |
CORK, CORK |
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Job Type: |
Permanent |
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Salary: |
€50 PER ANNUM |
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Role:
Reporting to the Quality manager, the successful candidate will have a strong technical background and a genuine passion for quality engineering.
Will demonstrate a critical thinking and problem solving mental attitude while maintaining a practical and hands on dynamic approach.
Will be a motivated self starter, while enjoying working in a team based environment. Will work within an Environmentally Controlled Area and have continuous participation in improvement of product quality for supply of medical devices used during orthopaedic, spine, neuro, plastic and ENT surgery.
Has responsibility for quality systems implementation & execution and product reliability whilst ensuring compliance to FDA Quality System Regulations and ISO.
Will actively drive the quality culture within the organization.
Responsibilities
The successful candidate will be responsible for quality related activities across a broad range of services and activities, including, but not limited to the following:
*Provide Quality Engineering support to environmentally controlled manufacturing and packaging areas. Have experience in a cleanroom manufacturing environment and knowledge of environmental control and monitoring techniques.
*Manage / execute site quality systems including CAPA, internal/external/supplier auditing, customer complaints, product release, validation, change control and QC testing.
*Lead Problem Solving, Failure & Root Cause Analysis, Risk Assessment & FMEAs, activities within the Team
*Knowledge of Product Traceability requirements, Labelling, Package Integrity and Design requirements.
*Provide quality engineering support for new product development.
*Management of multiple projects / tasks.
*Ensure Quality System compliance with world-wide regulatory requirements (ISO, FDA, QSRs) and have active involvement FDA, ISO & 3rd party regulatory audits.
*Support supplier management in Material Quality, Certification and Validation activities.
*Drive continuous Quality Improvement within the Business Unit.
*Assist customers in resolving product issues including customer complaints.
*Develop and implement Inspection Monitoring and Process Control procedures.
*Lead or execute Validation / Qualification activities within the Team, having knowledge/ experience in areas such as packaging, equipment, cleaning & process.
*Validation documentation authoring and review.
*Work within the business unit cross functional team to continuously improve its achievement of business goals
*Provide training in Quality Process', Procedures, Practices & Techniques to the extended production and technical Team
Experience and Qualifications Required
*The successful candidate will be qualified to degree level in an engineering or science related discipline with significant relevant experience.
*We require a candidate with previous experience in a quality engineering or engineering role, ideally in a regulated environment.
*Excellent analytical, problem solving and interpersonal skills are required.
Contact & Confidentiality
Please forward your cv in strictest confidence to Clodagh at CBSbutler Recruitment Ltd or call 021-421 7441 if you would like to discuss further options about this or other employment opportunities.
CBSbutler Recruitment is a professional organization where all CV's will be kept confidential and will not be submitted to any potential employer without your prior knowledge, discussion & consent.
Should you wish to view other suitable roles which may match your skillset and experience more accurately, please visit our website for a listing of all vacancies within the medical device/pharmaceutical and other industry sectors including Operations & Manufacturing, Quality, Technical & Engineering, Supply Chain, IT, HR.
Key Words; Pharmaceutical, Biotechnical, Bio-pharmaceutical, Regulatory affairs, CSV, Process Validation, FDA, GMP, Mechanical, Engineering, Engineer, technician, Automation, design, machine, Quality, Quality Engineer, Compliance, Product, Production, Manufacturing, Validation, Equipment, Testing, Medical Devices, Cork, Waterford, Tipperary, Kilkenny, Munster.
