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Lead quality assurance specialist

Galway
beBeeQualityEngineer
Quality assurance specialist
Posted: 1 August
Offer description

Job Title: Senior Quality Systems Engineer

Our company is a growing Medical Device firm that has recently relocated to a high-tech site in Parkmore.

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

The successful candidate will ensure our quality systems are compliant with various regulatory requirements including:

* 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.

Key Responsibilities:

* Maintenance and continuous improvement of the quality management system.
* Act as Coordinator for CAPA, Complaints & Temporary Authorization (Deviations) processes to support owners in meeting required timelines.
* Review and approval of Non-conformance, CAPA and Complaint investigation reports.

Requirements:

* Minimum Diploma Level in an Engineering, Science or Quality Assurance discipline.
* Training/Qualification in Quality Systems, Complaints and CAPA is highly desirable.
* At least five years' relevant 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.

Benefits:

* Hybrid working arrangement.
* Bonus scheme.
* Pension scheme.
* Healthcare benefits.

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