Senior Quality Systems Engineer

Role :

Senior Quality Systems Engineer

Location :

Parkmore, Galway (Hybrid working)

Benefits :

Top salary, hybrid working, bonus, pension and healthcare

Company :

My client are a growing Medical Device company who have recently moved into a high tech new site in Parkmore.

They have developed an innovative new technology to improve the performance of Vascular stents.

Role :

Reporting to the Quality Systems Manager, as a Senior Quality Systems Engineer you will play a key role in the implementation and maintenance of the company's Quality Management System.This is a fantastic opportunity, which will allow you to work as part of a supportive, collaborative team in our state-of-the-art facility here in Galway.

Responsibilities :

Ensure the Veryan Quality Systems are compliant with, the Medical Device Directive 93 / 42 / EEC, Medical Device Directive 2007 / 47 / EC, Medical Device Regulation 2017 / 745, FDA Quality System Regulations 21 CFR § 820 & 803, ISO 13485, ISO 14971 and Japanese Ministerial Ordinance # 169.

Maintenance and continuous improvement of the quality management systems.

Act as Coordinator for CAPA, Complaints & Temporary Authorization (Deviations) processes to support the owners in meeting required timelines.

Review & approval of Non-conformance, CAPA and Complaint investigation reports.

Act as Coordinator for the Audit Management Process.

Manage the annual audit schedule and coordinate internal and external audits as required.

Track audit actions from initiation to closure.

Coordinate activities in the preparation and management of audits by regulatory bodies.

Manage Quality Systems data collection and analysis to facilitate timely generation of Monthly Reports, Management Review data etc.

Prepare and present data to management on quality system performance, including Monthly Quality Reports.

Generate Quality Systems data as required for Post Market Surveillance purposes.

Act as a primary contact for other departments providing quality oversight to ensure compliance and promote quality improvements.

Provide quality review on a range of documentation including procedures, specifications, investigations, and other Quality Management System documentation as required.

Role :

Senior Quality Systems Engineer

Location :

Parkmore, Galway (Hybrid working)

Benefits :

Top salary, hybrid working, bonus, pension and healthcare

Company :

My client are a growing Medical Device company who have recently moved into a high tech new site in Parkmore.

They have developed an innovative new technology to improve the performance of Vascular stents.

Role :

Reporting to the Quality Systems Manager, as a Senior Quality Systems Engineer you will play a key role in the implementation and maintenance of the company's Quality Management System.This is a fantastic opportunity, which will allow you to work as part of a supportive, collaborative team in our state-of-the-art facility here in Galway.

Responsibilities :

Ensure the Veryan Quality Systems are compliant with, the Medical Device Directive 93 / 42 / EEC, Medical Device Directive 2007 / 47 / EC, Medical Device Regulation 2017 / 745, FDA Quality System Regulations 21 CFR § 820 & 803, ISO 13485, ISO 14971 and Japanese Ministerial Ordinance # 169.

Maintenance and continuous improvement of the quality management systems.

Act as Coordinator for CAPA, Complaints & Temporary Authorization (Deviations) processes to support the owners in meeting required timelines.

Review & approval of Non-conformance, CAPA and Complaint investigation reports.

Act as Coordinator for the Audit Management Process.

Manage the annual audit schedule and coordinate internal and external audits as required.

Track audit actions from initiation to closure.

Coordinate activities in the preparation and management of audits by regulatory bodies.

Manage Quality Systems data collection and analysis to facilitate timely generation of Monthly Reports, Management Review data etc.

Prepare and present data to management on quality system performance, including Monthly Quality Reports.

Generate Quality Systems data as required for Post Market Surveillance purposes.

Act as a primary contact for other departments providing quality oversight to ensure compliance and promote quality improvements.

Provide quality review on a range of documentation including procedures, specifications, investigations, and other Quality Management System documentation as required.

Education & Training

Educated at a minimum to a Diploma Level in an Engineering, Science, or Quality Assurance discipline.

Training / Qualification in Quality Systems, Complaints and CAPA is highly desirable.

A minimum of five years' relevent experience in the medical device industry.

Familiarity of ISO13485, ISO14971, Medical Device Regulation 2017 / 745 and FDA QSRs is required.

Experience in management of Quality Systems activities, in particular Complaints and CAPA is desirable.

To apply for more info call me on 087 0612325 or email

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