Quality Engineer

Sigmar Recruitment

Galway

Quality Engineer: This challenging position will require an ability to work with minimum supervision, pursue continuous improvement and ensure compliance to the Company Medical Quality System. If you want more responsibility and a varied workload then this is the role for you. This is the perfect opportunity to take the next step to progressing your career! For more information on this role please contact Rachael on 091 455306 or rbrennan@sigmar.ie. Key Job Responsibilities: Overall responsibility for production GMP standards and compliance. Investigation of root cause and following through on effective corrective actions to prevent re-occurrence for customer and internal quality issues. Establishing inspection standards, plans, frequencies and test methods. Establishing and maintaining FMEA’s. Preparing and updating Operations procedures and associated documentation. Reporting area of responsibility metrics. Supporting customer and surveillance accreditation audits. The quality engineer will perform an active role in quality planning and new product introduction from a quality perspective. Have a good working knowledge of ISO/FDA/MDD and other Product Development related regulatory requirements. Maintain relevant documentation to comply with quality standards and customer requirements. Develop strong links with customer organisation’s and other project stakeholders. Quality review of responsible area validation documentation. Performing an active role in further development and continuous improvement of the quality management system. Support Operations area projects and initiatives i.e. Kaizen, CFPS, etc. Other duties as assigned from time to time. Job Requirements: Degree in Quality or Degree in Science / Engineering. Experience within a similar role as quality engineer. 5+yrs industry experience in a medical device-manufacturing or pharmaceutical environment. Working knowledge of FDA and ISO Quality systems for Medical device companies. New product introduction and manufacturing process transfer experience would be a distinct advantage. Quality experience in component and device manufacturing desirable. Excellent written and oral communication skills essential. To apply send your CV or call Rachael on 091455306for more information. All applications are dealt with in strict confidence. Sigmar will never send your CV to a third party without your consent. This job originally appeared on RecruitIreland.com.

2795 days ago