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Quality Systems Engineer.

Reference:AMXL-431624 Location: Westmeath
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Quality Engineer

Quality Systems Engineer

Job purpose

Improve and Maintain the quality management system (QMS) in line with ISO13485, ISO9001, 21CFR 820 and Medical Devices Directive.

Key responsibilities will include (but are not limited to) the following:
• Quality system compliance to ISO13485, ISO9001, 21CFR 820 and Medical Devices Directive
• Ability to implement and improve a QMS
• Maintain and support the Internal Audit System
• Conduct Internal Audits
• Quality System support in Audit back rooms for Regulatory and Corporate Audits
• Provide Quality Systems support to all areas of the QMS, ensuring compliance is maintained at all times
• Support the Management Review process at both a local and regional level
• Provide inputs to KPI’s and Management Review
• Coordination, documentation and presentation for the Product Ship Hold process including analysis of results and any required actions
• Support Quality System related project activity as required
• Prepare, implement and analyse key Quality Systems related documentation
• Provide input and support to the CAPA system
• Coordinate and facilitate cross-functional issue reviews as required to support QMS activity
• Provide periodic training for company personnel on the company’s Quality Systems processes and procedures
• Pro-actively drive improvements in the quality systems area
• Interface with key business partners e.g. Manufacturing, Executive Management, Regulatory Affairs, PMS team and other functions as required.

Essential skills / Experience
• Engineering / Science degree or equivalent with 2-4 years experience in medical device or pharmaceutical environment or equivalent – essential
• Internal Auditor qualification – desirable
• Lead Auditor qualification - desirable
• Excellent working knowledge and proven track record in the all aspects of the Medical Device Directive, QSR and ISO quality requirements is required
• Excellent problem solving, root cause analysis, decision-making skills and technical writing skills are required
• Excellent organizational and project management skills, ability to effectively manage multiple projects. Attention to detail and accuracy – essential
• The ability to prioritize tasks and be able to manage several projects and tasks simultaneously; and the ability to interface with all levels of management
• Strong analytical reasoning and ability to work well under deadlines and pressure – essential
• Problem solving skills for developing creative solutions and meeting objectives are required
• Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MS Project, Outlook and Excel)

Key Relationships / Interfaces
• Multi-site QARA interaction
• Site QA Directors and Management
• VP of QA/RA
• Global QA/RA Team
• Global Operations and Logistics
• R&D
• Customer Service
• Marketing Communications

• Self-driven and ability to work independently and/or as a team player.
• Approachable and enthusiastic .Flexible and adaptable.
• Good organizational skills with cultural awareness and sensitivity
• Good judgment and problem solving ability & is capable of understanding the impact of decision making on both the company and their customers.
• Strong collaboration and influencing skills – both internally and externally
• Excellent communication skills – both verbal and written
• Goal orientated for customer and business objectives
• Coaching/Mentoring skills

Clodagh Nerney | Tel: +353 (0) 1 507 9254