Quality Systems Engineer

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Job title: Quality Systems Engineer - 12 month fixed term contractLocation: Finisklin, SligoBenefits: Excellent salary and bonus on offer. Role:Reporting to the Quality & Regulatory Affairs Manager, the Quality Systems Engineer will have responsibility for the management and effectiveness of the Quality Process. including reporting and communication.This position will provide Quality Support to Manufacturing in the areas of Process Control, Metrology, Product Quality, Procedural and System Audits, Document Change/ Control, Random Inspections and Training.The Quality Systems Engineer will develop and implement continuous improvement initiatives and preventive measures to achieve quality targetsCompany:My client based in Finisklin business park are a single-source solutions provider to the medical device and pharmaceutical sector. Specialising in the design, manufacture, and validation of multi-cavity injection moulds for high volume applications and complex injection-moulded thermoplastic and silicone solutions. ResponsibilitiesEnsures Quality Systems are implemented and continuously reviewed to ensure compliance with ISO9001 and ISO13485 Quality Management System.Manage and participate in the internal QMS Audit process- Ensure issues arising are communicated and action taken as appropriate.Participate and interface in external auditsLiaise directly with external auditors, customers and corporate on matters concerning quality and corrective preventive action activities arising from product/ system noncompliance.Develop collaborative relationships with all internal and external stakeholders and share best practices.Supplier approval, auditing and performance monitoring.QMS Documentation Control /Record Keeping.Prepare inputs for Management review.Drive quality improvement programmes to achieve performance targets in areas such as audit compliance, reduced complaint levels, NCR and CAPAs, and recommend enhancements to existing practices, equipment or processes to achieve required quality.Initiate product hold /containment actions, including completion of non-conforming reports, quarantine notice and any associated rework instruction ? Review & approval of process and equipment validation/ qualification.Establish and support development of quality assurance strategies, processes, guidelines and control plans which assure quality and reliability of manufactured products. Requirements: Degree in a Quality, Science or Engineering discipline.Minimum of 2 years relevant experience in a Quality role essential, preferably in the Medical Device or Pharmaceutical IndustryStrong knowledge and application of quality system regulations and ISO standards, and able to support an environment that meets the quality goals of the company. Would you be interested in reviewing the job spec?

If you are interested in hbearing more about this position and company forward an up to date CV and we can organise a call to discuss further. Please click here to find out more about our Key Information Documents. Please note that the documents provided contain generic information. If we are successful in finding you an assignment, you will receive a Key Information Document which will be specific to the vendor set-up you have chosen and your placement.To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales