Quality Engineer - County Longford.
In this role you will be responsible for supporting all Quality aspects impacting the successful functioning of the manufacturing facility.
You will report to the Quality Manager and will support the organisation to achieve the quality objectives.
Core Job Duties and Responsibilities: Developing and implementing solutions to sustain and improve the QMS.
Maintain and support compliance to ISO 13485 and ISO 14001 systems standards.
Interface with customers on new products, quality issues and Process Qualifications.
Develop and implement process control programs to ensure customer requirements are met Carry out process validations and qualification on products.
Provides manufacturing support and Quality expertise in relation to Manufacturing issues and product disposition Performing quality engineering analysis to identify strategies to prevent quality non-conformances and minimize risk.
Co-ordinate NCR / CAPA Process to ensure timely resolution and closure of issues.
Lead training activities on Quality Procedures e.g.
Compliance, GMP, Audit Prep and GDP.
Supporting and representing the site during external audits and carrying out Internal Audits.
Trending and tracking of quality data to support quality improvements across the business.
Supporting Environmental, Health and Safety requirements, training, and regulations.
Requirements for this role: Third level qualification in Engineering, Polymer Science, or equivalent Manufacturing experience.
Experience in statistical analysis (Minitab) / SPC / validations.
Excellent interpersonal, communication, influencing, and facilitation skills A minimum of 3 years experience as a Quality Assurance Engineer within an injection moulding or medical manufacturing environment or similar.
Skills: quality engineer medical device injection moulding