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QA VALIDATION ENGINEER - SLIGO

 

Company:

COLLINS MCNICHOLAS RECRUITMENT
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Job Reference Number

14565321

Client ID:

RI/SJ36541
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Posted On:

Feb 3 2012

Location:

SLIGO
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Job Type:

Contract

Salary:

NEGOTIABLE
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Our client, a US Multinational healthcare organisation in Sligo is currently seeking to recruit a QA Validation Engineer for a contract period of 6 months.

Job Description:
Reporting to the QA Team Manager your responsibilities will include:
• Support validation and change control programmes, as part of the quality system.
• Interact with team colleagues, internal and external customers on validation plans, validation IQ, OQ and PQ protocols.
• Maintain the validation requirements in compliance with ISO 13485 and US FDA requirements.
• Verify, review and approve validation reports and deliverables.
• Coordinate execution activities such as documentation, sampling and inspection as well as verifications requirements.
• Participate in quality systems internal audit and reporting.
• Support tracking, trending and reporting of regular performance metrics.
• Provide effective quality assurance support to technical personnel during project planning and execution.

Requirements:
• Educated to Degree level in Quality Assurance, Science, Engineering or related discipline.
• Experience with injection moulding, automated assembly or computerized systems for medical devices would be advantageous.
• At least 3 years experince in a Validation role

• Proven knowledge of ISO / EN / FDA validation and change control regulations as they relate to medical devices.
• Extensive knowledge and familiarity with validation requirements of production equipment, injection moulding equipment, metrology equipment and computerized systems.
• Appreciation/knowledge of current medical device regulatory environment.
• Excellent communication and interpersonal skills.
• Enthusiastic and energetic with the ability to integrate quickly into a team environment.
• Flexible and innovative approach to work.

For further information please contact Antoinette O’Flaherty on 071-9142411 or email your CV in confidence antoinette.oflaherty@collinsmcnicholas.ie