Description
Quality Systems Engineer - New Product Introductions:My Galway based client is seeking an experienced Quality Systems Engineer to ensure all Quality and Regulatory systems are effective and to provide assurance of compliance to defined product and customer requirements.
The Quality Systems Engineer role will involve:
-Quality System: Ensure compliance to ISO 13485, 9001:2000, 21CFR 820 and other medical device standards and ensure effectiveness of system.
Promote awareness of the above throughout the organisation through regular training/briefing sessions. Integrate with corporate requirements and promote synergy/consistency with other sites.
-Quality System Audits: Conduct quality system audits and follow up on corrective action programmes
-Quality Performance: Review and track key quality performance indicators.
Corrective Action Management: Ensure an effective CAPA programme to include disposition of product, non-conformances and customer complaints etc.
-Documentation: Manage documentation system to include Engineering Change Notices, amendment Requests, manufacturing records etc
Product Transfers: Represent Quality Dept in product transfers by providing resources, technical knowledge and expertise. Set goals and objectives and timelines for completion. Provide reports and updates on progress on key metrics
-Project Management: Monitor and control progress of projects to ensure compliance with internal quality system and ISO requirements
-Manufacturing Support: Provide timely support and solutions to manufacturing issues, ensuring compliance with Quality Management System and ISO requirements
Supplier Quality: Coordinate and supervise the SQA activity in achieving expected results
-Validation: Liaise with Engineering Dept to ensure all new equipment is validated as per MVP. Provide resources to participate in OQ/PQ and IQ activities
-Regulatory Support: Good knowledge of the Regulations e.g. MDD, 21 CFR, JPAL and CMDCAS when dealing with Class I, IIa and IIb Medical Devices.
Skills required:
Minimum 5 years experience of Medical Device or Pharma manufacturing environment
Experience with New product introductions
Degree or higher qualification in Science/Engineering or equivalent.
Lean Six Sigma and TPM knowledge and experience
Good working knowledge of regulatory expectations and industry practices including QSR, ISO13485, MDD.
This is an exciting role which will give you a great opportunity to develop your skill sets and work with a highly experienced team. An excellent salary of €40,000 - €50,000 is on offer.
If you are interested in this position please contact me Adele Moran on for more information and immediate consideration. Interviews will be immediate.
To find out more about Real please visit www.realstaffing.com