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June 20 2018

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Job Offer: Senior Quality System Engineer:Aerogen Ltd.

Job description:

Senior Quality System Engineer

Aerogen Ltd.

   » Galway
   » Negotiable
   » Permanent full-time
   » Updated 14/06/2018
   » HR Manager this job is expired SaveSave Apply Now

Job detail

Manage key elements of the Quality System to ensure compliance to significant standards for the business including EN ISO13485, FDA QSR.

Job Summary:
Manage key elements of the Quality System to ensure compliance to significant standards for the business including EN ISO13485, FDA QSR. The function will take the lead in ensuring that the quality system is maintained and implemented in a compliant manner and areas of improvement are identified and implemented as required. This will involve coordinating and working with all functions in a collaborative manner where quality system compliance is dependent. Also work with the R&D team and being responsible for Medical Product (CE Mark and FDA 510k) Design Assurance and Risk Management Activities on individual projects that are assigned.

Authority Assignment:
In the absence of the QA/RA Director the Senior QS Engineer will report to the Managing Director.

tasks/The main responsibilities are:
• Coordinate the Internal Audit system and Audit Team to ensure that all audits are completed in a thorough and timely manner. Conduct Quality Audits as necessary.
• Lead preparation and coordination activities for external audits and contact as required with SME's to ensure audits are conducted in an efficient manner.
• Manage all aspects of the Document Control Function in conjunction with the appropriate resources.
• Identify and initiate action to address any adverse trends or regulatory compliance issues in a timely manner.
• Coordinate the Non-Conforming and CAPA system to ensure that all NC/CAPAs are completed in a thorough and timely manner.
• Identifies any opportunities for improvement within the quality system procedures and practices in association with the appropriate internal groups.
• Promotes the consciousness of regulatory and customer requirements all over the organization.
• Supports Quality training on site.
• Methodical review approach and be capable of initiating and leading change and continuous improvement.

• A degree in Engineering, Technology, or Science
• At least 7 years practice working in a regulated device or pharmaceutical company.
• Excellent planning and coordination expertise.
• Excellent verbal and written communication expertise.
• Excellent attention to detail expertise

S pecific Requirements:
Previous practice in leading or participating in external notified body or regulatory audits.

Environmental Conditions:
Typical office environments, with work also performed in R&D and manufacturing labs, and customer/supplier locations.
Ref: Aero 071CCCCCCCCC
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Aerogen Ltd.


   » Galway Business Park, Dangan, Galway
   » 091 540 400


Job Category: Customer Service [ View All Customer Service Jobs ]
Language requirements:
Employment type:
Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
Job Location: Galway
Company Type Employer
Post Date: 06/14/2018 / Viewed 12 times
Contact Information
Company: Aerogen Ltd.

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