Senior Quality Engineer
Posted on Oct 2, 2020 by Real Staffing Group
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.
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.
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.
- 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.
- 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