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Quality Engineer - Operations

Real Staffing Group

Posted on Feb 19, 2021 by Real Staffing Group

Galway, Ireland
Engineering
Immediate Start
Annual Salary
Full-Time


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 ie Kaizen, data analysis, problem-solving tools, etc.


Experience required:
* 2+ years exp as a Quality Engineer
* Medical Device manufacturing environment.
* Level 8 degree


Forward your application for more info on this interesting new opportunity.


Look forward to hearing from you


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




Reference: 1101313058

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