Our client, a privately owned Irish company based in Longford, is seeking to recruit an ambitious Quality Engineer.
Key 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 track of quality data to support quality improvements across the business
* Supporting Environmental, Health and Safety requirements, training, and regulations
* Perform additional duties at the request of the direct supervisor
Qualifications & Key Attributes:
* 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