Quality Engineer - Operations

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Title: Quality Engineer

Location: Parkmore Galway

Benefits: Excellent career progression, top salary, pension, healthcare, yearly bonus, flexible working hours and time to work on own product ideas.

Company:

My client is among the top 10 global companies in the medical device outsourcing industry. The company specializes in the design and manufacture of minimally invasive delivery and access devices for a range of therapies. Serving over 400 companies across 30 countries.

Role:

The successful candidate will be responsible for Operations Quality within their prescribed area of functional responsibility. They will be working as part of a team to maintain high quality/performance standards on all Medical products.This challenging position will require an ability to work within a collaborative environment, pursuing continuous improvement and ensuring compliance to the Quality System. The focus of the role is to supply high-quality medical devices and components to deliver an Extraordinary Customer Experience.

Responsibilities:

Working with the Supervisors and Manufacturing Engineering, promote the achievement of the health and safety goals.

* To deliver on all KPIs that help the business achieve its goal.

* The Operations Quality Engineer will perform an active role in further development and continuous improvement of the Quality Management system

* Establish and maintain risk management principles and methods throughout the product realisation process in compliance with the company's Quality Management system and ISO14971

* Maintain relevant documentation to comply with quality standards and customer requirements.

* Offer quality guidance to a team of Quality Technicians in support of the day-to-day manufacturing operations.

* Develop strong links with customer organisation's and other project stakeholders.

* Quality review of responsible area validation documentation.

* Investigation of root cause and implementation of effective corrective actions to prevent re-occurrence of compliance issues.

* Overall responsibility for production GMP standards and compliance.

* Establish inspection standards, sampling plans and test methods.

* Prepare and update Operations procedures and associated documentation.

* Support customer audits and surveillance/accreditation audits

* Conduct audits of the Manufacturing Operation and the Quality System ensuring compliance with ISO13485.

* Support Operations area projects and initiatives i.e. Kaizen, data analysis, problem-solving tools, etc.

Experience required:

* 2+ years exp as a Quality Engineer

* Medical Device manufacturing environment.

* Level 8 degreeForward your application for more info on this interesting new opportunity.Look forward to hearing from you To find out more about Real please visit www.realstaffing.comReal 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