Posted on Apr 21, 2020 by Real Staffing Group
Title: Quality Leader
Location: Dangan, Galway
Benefits: Excellent career progression, Excellent salary, pension, healthcare, dental and a yearly bonus.
With a brand new site in Galway my client invests heavily in research and development to evolve its pioneering product range and change the future of respiratory patient care.
Section Leader Manufacturing Quality is responsible for leading quality engineering and quality system activities for manufacturing processes, materials and products. This role is completed with support from the Quality Systems and Supplier Quality functions.
Lead Quality Engineering and Quality Systems support the Manufacturing at site driving process continuous improvements and providing manufacturing support.
- Process/manufacturing data analysis, trending, and assisting yield reporting.
- Investigation root cause analysis of quality issues in manufacturing and managing quality related NC's and CAPA's
- Establish analysis techniques and other quality control tools such as SPC, Cpk, Ppk.
- Lead the Materials Review Board (MRB) process
- Champion continuous process improvement and in conjunction with other functions, analyse feedback and identify and implement appropriate problem solving and statistical techniques to improve quality of manufactured product and overall effectiveness and efficiency of processes.
- Establish inspection plans, frequencies and test methods for incoming material/parts.
- Overall responsibility for GMP standards and compliance within manufacturing area
- Lead Master Validation Process Plans and Process Validations.
- Drive risk management activities in manufacturing (Process FMECA).
- Manage process quality control system to ensure all manufactured product meets defined specifications prior to shipment.
- Manage assigned aspects of the quality system in compliance with ISO 13485:2016: FDA QSR, MDSAP requirements.
- Conduct internal audits as defined by audit schedules and ensure ongoing high level of readiness for all external audits.
- Degree in Engineering, Technology or Science. A Post-graduate qualification in Quality Assurance is preferable although not mandatory.
- 5+ years Quality/Quality Engineering experience or a related role within the medical device industry.
- Ability to liaise with suppliers, customers and regulatory contacts in an informed professional manner.
- Excellent understanding of EN ISO 13485:2016, MDSAP and FDA requirements
- Must have a working visa for Ireland
If you would like to hear more about this exciting new company to Galway and discuss the position available get in touch with an up to date CV and we can discuss it further.
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