Senior Quality Engineer - West Galway


Premium Job From Real Staffing

Recruiter

Real Staffing

Listed on

27th September 2018

Location

Galway

Salary/Rate

£46167 - £54561

Type

Permanent

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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.). It's approx. 15 mins drive from the city.

The role:

Due to my client's expansion plans, they're looking for a Senior Quality Engineer to join them on a permanent basis. At present, there are approx. 60 people in the company. And you'll be reporting to the QA/RA Manager. Some of your responsibilities will include:

* Act as the QA representative on Design Services Projects supporting new product introductions, qualification of new suppliers, development and approval of new product documentation.

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

* Initiate / Approve Validation protocols and reports (IQ, OQ, PQ)

* Initiate / Approve 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 / Approve Reworks

* Initiate / Support implementation of effective Corrective / Preventive Actions

* Champion continuous improvement through CAPA system, handling of complaints, analysing key performance indicators etc.

* 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 the Environmental monitoring process

* Support activities associated with Sterilization

* Act as the QA representative for Supplier Quality management activities

* Collate and trend Key performance indicator data

* Actively participate in Management Review & Compliance meetings

* Act as delegate for Quality Manager when required

Your profile:

You're a quality/design/development professional with 5+ years' experience at engineering level in the healthcare (medical device / pharma / diagnostics) industry. You have strong working knowledge of current regulatory standards in a medical device / ISO 13485 industry, applicable in a design-orientated role. If you have experience working with vascular medical devices, this would be an advantage. If you see yourself as a good all-round design assurance/quality engineer, looking for a Senior Quality Engineer opportunities, then this could be the job for you!

The offer:

Permanent contract, healthcare for you and family, pension contribution, training & development support.

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

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