Quality Engineer
- Dublin, Ireland
- €50,000 - €65,000 per annum
- 76 applications
- Job type: Permanent, full-time
- Date:
- Reference: 17483544
Posted by
HRM Executive Recruitment More jobs from HRM Executive Recruitment
HRM Executive Recruitment More jobs from HRM Executive Recruitment
This company is a medical technology company that serves healthcare institutions, life science researchers, clinical labs, industry and the general public. Based in Dublin, it has offices in nearly 50 countries worldwide and remains one of the largest medical device manufacturers in the world. Currently a need for a Quality Systems Manager has arisen in their plant in Dublin.
JOB PURPOSE
You will play a pivotal role in site process improvement activities, with specific focus on Moulding support. Reporting to the Quality Engineering Manager, duties will include management and execution of process validation studies, active participation in process improvement projects, project management, application of SPC to current production processes and liaison with key customers.
RESPONSIBILITIES
o Coordinating the activities of the Quality resources allocated to the Moulding department to ensure optimal efficiency and compliance with all regulatory requirements.
o Drive and maintain cGMP practice within the Moulding department.
o Preparation, review and approval of technical documentation
o Ensure all Moulding related CAPA’s are completed in compliance with all regulatory and procedural commitments.
o Become an active member of the site internal audit team, liaising with Regulatory auditors
o Devise and implement Six Sigma continuous improvement projects (2 per annum)
o Ensure Moulding support area operates in accordance with current best practice.
o Act as customer liaison contact for given key customers.
o Review, analyse and report on relevant customer complaints.
o To carry out Quality and Regulatory Compliance functions within the Quality Engineering Team
o EDUCATIONAL REQUIREMENTS
Third level qualification in a Science/Engineering discipline (Preferably Polymer Science/Engineering or Mechanical Engineering)
RELEVANT EXPERIENCE
o 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.
o Experience in the preparation of Technical Documentation.
o Knowledge of Statistical Process Control and Six Sigma methodologies (Greenbelt Certification would be advantageous). You will be required to achieve Blackbelt certification.
o Experience in CAPA system management
o A working knowledge of FDA requirements and managing FDA audits.
o Experience in moulding, process validation and working in a clean room environment.
o Proven ability of working in a cross-functional team environment.
o Excellent interpersonal and communication skills.
o High level of computer literacy.
For immediate consideration for this role please apply online or contact:
Shane Browne - (01) 632 1865
HRM Science Selection Team
YOUR CV WILL BE TREATED WITH THE STRICTEST CONFIDENCE
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We Always Want to Hear From
[Consultants] [Laboratory Technicians] [Lab Analysts] [Health & Safety Officers]
[Scientists] [Medical Scientists] [Quality Control Analysts] [Quality Assurance Analysts] [Doctors] [Chemists] [Analytical Chemists] [Pharmacologists] [Biochemists] [Microbiologists] [Quality Managers] [Radiographers] [Quality Engineers] [Qualified Persons] [Pharmacists] and all other scientific and medical professionals...
We Can Offer You
[Expert Advice] [Interview Tips, Techniques & Strategy] [Salary & Benefits Advice] [Career Counselling]
[A Smooth Straightforward Recruitment Process from Start-to-Finish]
JOB PURPOSE
You will play a pivotal role in site process improvement activities, with specific focus on Moulding support. Reporting to the Quality Engineering Manager, duties will include management and execution of process validation studies, active participation in process improvement projects, project management, application of SPC to current production processes and liaison with key customers.
RESPONSIBILITIES
o Coordinating the activities of the Quality resources allocated to the Moulding department to ensure optimal efficiency and compliance with all regulatory requirements.
o Drive and maintain cGMP practice within the Moulding department.
o Preparation, review and approval of technical documentation
o Ensure all Moulding related CAPA’s are completed in compliance with all regulatory and procedural commitments.
o Become an active member of the site internal audit team, liaising with Regulatory auditors
o Devise and implement Six Sigma continuous improvement projects (2 per annum)
o Ensure Moulding support area operates in accordance with current best practice.
o Act as customer liaison contact for given key customers.
o Review, analyse and report on relevant customer complaints.
o To carry out Quality and Regulatory Compliance functions within the Quality Engineering Team
o EDUCATIONAL REQUIREMENTS
Third level qualification in a Science/Engineering discipline (Preferably Polymer Science/Engineering or Mechanical Engineering)
RELEVANT EXPERIENCE
o 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.
o Experience in the preparation of Technical Documentation.
o Knowledge of Statistical Process Control and Six Sigma methodologies (Greenbelt Certification would be advantageous). You will be required to achieve Blackbelt certification.
o Experience in CAPA system management
o A working knowledge of FDA requirements and managing FDA audits.
o Experience in moulding, process validation and working in a clean room environment.
o Proven ability of working in a cross-functional team environment.
o Excellent interpersonal and communication skills.
o High level of computer literacy.
For immediate consideration for this role please apply online or contact:
Shane Browne - (01) 632 1865
HRM Science Selection Team
YOUR CV WILL BE TREATED WITH THE STRICTEST CONFIDENCE
Specialists in
[Scientific Jobs] [Pharmaceutical Jobs] [Biotechnology Jobs] [Laboratory Jobs] [Chemistry Jobs] [Quality Jobs] [Clinical Jobs] [Graduate Jobs] [Medical Jobs] [Food Jobs] [Medical Device Jobs] [Pharmacy Jobs] [Clinical Research Jobs] [Nursing Jobs] [Dublin Jobs] [Irish Jobs] [Science Jobs] [Engineering Jobs] [Radiography Jobs] [Regulatory Affairs Jobs] [Analytical Jobs] [Microbiology Jobs]
We Always Want to Hear From
[Consultants] [Laboratory Technicians] [Lab Analysts] [Health & Safety Officers]
[Scientists] [Medical Scientists] [Quality Control Analysts] [Quality Assurance Analysts] [Doctors] [Chemists] [Analytical Chemists] [Pharmacologists] [Biochemists] [Microbiologists] [Quality Managers] [Radiographers] [Quality Engineers] [Qualified Persons] [Pharmacists] and all other scientific and medical professionals...
We Can Offer You
[Expert Advice] [Interview Tips, Techniques & Strategy] [Salary & Benefits Advice] [Career Counselling]
[A Smooth Straightforward Recruitment Process from Start-to-Finish]
