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Senior Quality System Engineer - Ireland  

Aerogen (company)


Posted on : 10 July 2017

Project Description

Job Summary
  • Manage key elements of the Quality System to ensure compliance to relevant standards for the business including EN ISO13485, FDA QSR.
  •  The role 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.

Duties / Responsibilities
  • 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 liaise 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 awareness of regulatory and customer requirements throughout the organization.
  • Supports Quality training on site.
  • Methodical review approach and be capable of initiating and leading change and continuous improvement.

Specific Requirements
Previous experience in leading or participating in external notified body or regulatory audits.

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

Some of the benefits our employees enjoy:
  • VHI including Dental
  • Pension
  • Bonus
  • DIS
  • PHI
  • On-site Free Parking
  • Paid Holidays
  • Sports & Social Club
  • Flexi- Start Time.