Quality Engineer - Operations
Posted on Feb 19, 2021 by Real Staffing Group
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.
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.
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.
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.
* 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