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October 19 2018

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Job Offer: Quality Systems Engineer:

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Quality Systems Engineer

function Description

My client a global medical device company has a new and exciting function for a Quality Systems Engineer. You will be responsible for ensuring the effective and efficient deployment of the Quality System within the EMEA.


Your function will be to manage and maintain the EMEA Quality Management System in compliance with the Products Business Unit Quality System and the significant applicable standards and regulations, i.e. ISO, GMP, FDA including but not limited to the following processes:

Quality System Management: Management Review, Internal Audits, Document Control and Quality System Planning.
Training: Co-ordinate / lead quality system related training sessions for cross functional team attendance.
Supplier Management: Assure appropriate levels of controls and management of suppliers that have an impact on product quality and the Quality System.
Distribution: Assure support and control to the EMES distribution center.
Vigilance Reporting: Ensure on time reporting of vigilance reports and follow up significant EMEA Competent Authorities and Notified Bodies.
CAPA/ NC: Maintain compliance with requirements as well as escalating to upper management any major or critical nonconformance that may result from audits and/or any element of the Quality system.
Field actions: Assure timely and efficient execution of field actions in the EMEA.

1.2. Provide Quality system skills and expertise and support to EMEA and global sites.
1.3. Interface with local operations, with EMEA RA and actively participate with trade associations, competent authority and Notified Body meetings to ensure up to date intelligence is maintained.
1.4. Pro-actively perform data analysis to monitor quality systems performance and compliance and where necessary identify opportunities to improve the Quality System.
1.5. Coach, develop and mentor Quality employees.
1.6. Facilitate the consciousness of customer requirements all over the organization and ensure the complaints process improves the customer practice.
1.7. Encourage problem-solving processes leading to the implementation of solutions across divisions in EMEA.
1.8. Facilitate sharing of initiatives/ideas and accomplishments across the EMEA product business.


University degree, a minimum of 4 years.
Minimum 5 years practice in a Medical device industry or a similar environment. practice with CAPA, Change Management, Supplier Quality Assurance and Risk Management is required.
expertiseable in Quality Systems and Medical Device Regulations, i.e. ISO 9001, ISO 13485, MDD 93/42/EEC and FDA QSR.
capability to work on own initiate, be proactive and propose viable solutions to meet the business and customers needs.
Good communication skills, both oral and written.
Desire to lead change whilst meeting both the Business and Regulatory requirements.

2. ADDITIONAL Requirements:

2.1. capability to travel up to 10%

Do you have the following attributes?

A flexible approach to work and be capable of handling multiple priorities in a fast-paced environment.
Strong attention to detail with a high degree of accuracy and excellent organisational and communication skills.
capability to work with and empathise with colleagues and customers from varied backgrounds and cultures

For full detials send your curriculum Curriculum for or call Tina at +353 1 2784671


Job Category: Customer Service [ View All Customer Service Jobs ]
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Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
Job Location: Dublin West, Other
Company Type Employer
Post Date: 09/21/2018 / Viewed 60 times
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