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Senior Quality Engineer

Posted on Oct 2, 2020 by Real Staffing Group

Galway, Ireland
Engineering
Immediate Start
Annual Salary
Full-Time


Title: Senior Quality Engineer (Role will be looking after Quality Operations for new product line from the USA)


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:


As a Senior Quality Engineer you will get the opportunity to develop your people management skills with 6 direct reports of Engineers and Technicians. This is an exciting new project for my client who are building a new product line for a host of new products.


Manage the day to day activities of the team and provide Quality input and support to the Manufacturing, Engineering, Prototype and Commercial functions.


Responsibilities:



  • Manage the day to day activities of the team in a safe environment and be responsible for Health and Safety goals.

  • Lead and drive QA initiatives within area of functional responsibility.

  • Lead, coordinate & maintain risk assessment documentation eg FMEA's.

  • Investigate root cause of Quality issues and following through with timely and effective corrective actions to prevent re-occurrence for customer and internal issues.

  • Strategically lead new product introduction and contract reviews from a QA perspective.

  • Prepare and updating Operations procedures and associated documentation.

  • Overall responsibility for functional area GMP standards and compliance including the promotion of Quality awareness.

  • Establish inspection standards, sampling plans, and test methods.

  • Develop strong links with customer organisations and other project stakeholders.

  • Quality review of functional area validation documentation.

  • Perform and support internal and external audits to ISO and FDA requirements.

  • Perform an active role in further development and continuous improvement of the Quality Management system.

  • Supervision and direction of Quality personnel.

  • Other tasks as directed by the Operations Quality Manager in line with company goals and objectives.


Experience required:



  • 2+ years exp as a Senior Quality Engineer

  • People management exp. Direct reports = 3 Quality Techs, 3 QEs.

  • Medical Device manufacturing environment.


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




Reference: 962063782

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