7 days left
- Job Level
Contract Term: Permanent
Adecco are currently looking for a talented and motivated Quality Engineer who is interested in joining a leading medical device company in Waterford,
This is a permanent opportunity with the company that offers a salary between €45-55K, DOE.
Quality Engineers help to ensure that manufactured products meet company and customer quality specifications; they are also responsible for designing inspection sheets and assigning inspection levels and frequencies, troubleshooting Quality issues, and assisting Engineering, Production, and other Departments in maintaining the Quality Systems at Schivo Medical in compliance with ISO13485 and AS9100 requirements.
· Responsible for the cleanroom facility management (qualification/maintenance/ extensions) including HVAC and supportive utilities within a GMP compliant Quality Management System.
· Support NPI team in the execution of Performance Qualification (PQ) for cleanroom processes as per the project schedule.
· Responsible for planning and execution of Periodic Review and Revalidation activities for clean utilities, systems, and equipment.
· Maintains and implements environmental controls.
· Support deviation investigations throughout the facility.
· Serve as a subject-matter expert on validation activities during regulatory agency inspections
· Participate in risk assessments, inspections, audits, incident investigations, etc., and implement and follow-up related CAPA's as required.
· Create concise and accurate on-time technical reports. Clearly communicate results internally and to customers through the use of quality tools and statistical techniques.
· SME for appropriate statistical techniques to monitor process performance (e.g. SPC, Cp, Cpk, R&R analysis, sampling techniques, and other statistical techniques)
· Acts as the customer conduit for all quality-related issues, capable of articulating complex technical solutions to customers in a manner that's easily understood.
· Creates and evaluates metrics to drive tangible quality improvement.
· Evaluate materials, gather and analyze data and determine the root cause of problems using relevant corrective action systems (e.g. CAPA / 8D / A3 Problem Solving).
· Manage several projects simultaneously and coordinate multiple, changing deadlines
. A proven solutions provider that can work in a fast-paced environment across multiple projects with a customer focussed approach
. A process thinker with a proven track record for delivering value add to the bottom line through CI initiatives
. An individual of strong character who can challenge the norm in a professional manner, capable of articulating complex solutions to key stakeholders across organizations (internal & external)
. Exceptional technical report writing skills required with a logical flow to his / her approach
· Able to lead environmental monitoring programs for cleanroom activities.
· Can work effectively with minimal guidance.
· Honours (level 8) Degree in Mechanical/Manufacturing/Production Engineering or similar
. Knowledge of Reg requirements
. Knowledge of cleanroom environmental monitoring
· >5 Years' experience in a production environment
· >5 years' experience in a quality department
· >5 Customer Complaints Management experience
Sounds interesting? We look forward to discussing your next career move. Apply online and a Specialist Recruiter will be making contact shortly.
Adecco Ireland is acting as an Employment Agency in relation to this vacancy.
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♦ The business of the Adecco Group UK & Ireland is transacted via a number of differently branded trading entities, as follows: Adecco UK Limited, Adia Technology Limited, Modis International Limited, Badenoch and Clark Limited, Ajilon (UK) Limited, Office Angels Limited, Penna plc, Pontoon Europe Limited, Roevin Management Services Limited, Spring Technology Staffing Services Limited.