14407CW
quality engineer pharmaceutical medical surgical
Dublin North Dublin South Dublin West
60000 - 70000
5 - 6 Years
Permanent Full-time
See Description
Manpower Mature
mature@manpower.ie
AT MANPOWER IRELAND
OUR CLIENT
Medical Technology Company
THE JOB
Quality Engineer
EQUAL OPPORTUNITY EMPLOYER
BASED -
Dublin South
JOB PURPOSE
Reporting to the QA/RA Manager, Irish Operations, the Quality Engineering Manager will play a pivotal role in site process improvement activities and be the central point of contact for key customers. Duties will include management and execution of process validation studies, project management, application of SPC to current production processes and liaison with key stakeholders.
DUTIES
RESPONSIBILITIES:
§ To provide support for ISO9000/ISO13485 Quality System.
§ Responsible for ensuring adherence to all company, external and appropriate regulatory requirements.
§ Become a key member of the Quality Leadership Team.
§ Support production personnel in relevant continuous improvement activities (Six Sigma).
§ Day to day Leadership/Management of Quality Engineering Team.
§ Management of Key quality systems elements relating to direct production support such as the non- conformance system, incident reporting system and customer complaint analysis.
§ Management of Quality control group and their activities.
§ Driving key changes and improvements in the Quality assurance and control systems.
§ Liaise with key external customers.
§ Prepare and Maintain documentation in compliance with appropriate regulatory requirements.
§ Supporting key changes and improvements in manufacturing relating to product quality.
§ GMP oversight and compliance of Production and Quality Engineering activities.
THE CANDIDATE -
EDUCATIONAL REQUIREMENTS:
§ A primary degree in a Science/Engineering discipline.
§ A postgraduate qualification in a related area would be advantageous.
RELEVANT EXPERIENCE/REQUIREMENTS:
§ A minimum of 5 years work experience in an ISO 9001/2000 or ISO 13485 environment, coupled with a background in Medical Devices/Pharmaceutical Industry.
§ Experience in the preparation of Technical Documentation.
§ At least 3 years supervisory experience.
§ Knowledge of Statistical Process Control and Six Sigma methodologies (Greenbelt Certification would be advantageous).
§ Experience in CAPA system management.
§ A working knowledge of FDA requirements and managing FDA audits.
§ Experience in process validation, Sterilisation and working in a clean room environment would be advantageous.
§ Proven ability of working in a cross-functional team environment
SALARY
€60,000 - €70,000
CONTACT
Ciaran Williams 01 645 5215
Email your CV ASAP to register to scientificengineering@manpower.ie
www.manpower.ie
Excellent opportunity not to be missed !!!