Quality Engineer
We are seeking a Quality Engineer to join our team in Longford/Roscommon. The successful candidate will have the opportunity to work with a highly experienced and friendly team who have a wealth of knowledge in leadership roles.
This is an excellent opportunity for a quality technician looking to step up or an experienced professional with 3-5 years of experience in the medical device industry.
The ideal candidate will have prior medical device experience and be able to develop and implement solutions to sustain and improve the quality management system (QMS).
Key Responsibilities:
* Developing and implementing solutions to sustain and improve the QMS.
* Maintaining and supporting compliance to ISO 13485 and ISO 14001 systems standards.
* Interfacing with customers on new products, quality issues, and process qualifications.
* Developing and implementing process control programs to ensure customer requirements are met.
* Carrying out process validations and qualification on products.
* Providing 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.
* Coordinating NCR/CAPA processes to ensure timely resolution and closure of issues.
* Leading training activities on quality procedures, e.g., compliance, GMP, audit preparation, 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.
* Performing 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.