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 Thomas.gallagher@lifescience.ie

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