Quality Engineer

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The company:

Headquartered in Galway, my client has been delivering innovative solutions for medical implantable products for over 15 years, servicing many of the leading Tier 1 medical devices companies globally. They've established a comprehensive suite of product development and manufacturing capabilities, servicing the General Surgery market, including medical textiles, stent coating and encapsulation, and resorbable implants. A rebranding and restructuring strategy last year has allowed my client to position them to servicing key growth markets of Cardiovascular, General Surgery and Orthopaedics.

The location is ideal for anyone living in Galway City or to the west or Connemara (Salthill, Spiddal, Moycullen, Knocknacarra, Dangan etc.) Approx. 60 people work here, located about 15 mins drive from the city.

The role:

My client are looking for someone with to join them on an initial 9 month fixed term contract as Quality Engineer, You will work as part of a team to maintain high quality/performance standards across the company.

Reporting to the Senior Quality / Regulatory Manager, some of your responsibilities will include:

* Act as the QA representative on Design Services Projects / Changes

* Develop and maintain documentation in compliance with FDA , ISO, MDD requirements

* Initiate / Approve Validation protocols & reports (IQ, OQ, PQ) and Engineering Change notices

* Process Customer Complaints and manage customer replies

* Actively participate in the Documentation control process

* Initiate / Approve Non-Conformance Reports & Lead Root Cause analysis investigations

* Participate / Lead Risk Analysis initiatives e.g. FMEA

* Initiate / Support implementation of effective Corrective / Preventive Actions

* Represent QA as part of the Material Review Board

* Perform Internal and Supplier Audits

* Support Notified Body / Regulatory Agency / Customer Audits

* Review / Approve / Release final product documentation

* Support activities associated with Sterilization

* Act as the QA representative for Supplier Quality management activities

Your profile:

You have a scientific/technical/engineering degree (hons/level 8) with 3 yrs. experience of working as a Quality Engineer/similar within the Medical Device Industry. You thrive work in a busy, fast-paced environment and have experience in the above responsibilities. You'd like to work in a company with a company during an exciting growth phase.

If you think the position in Galway is the step in the right direction for you and have experience in a similar role, don't hesitate in applying. If you think you might be interested in becoming a Quality Engineer and looking for more information, I will contact you upon application and discuss this further with you! *EU passport/Stamp 4 Visa needed for consideration - sponsorship is not offered with this role.

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales