Quality Engineer
Medical Device
Longford/Roscommon
CPL Recruitment is assisting a valued client in sourcing quality engineers to join their team. The site has undergone significant investment and expansion, requiring the need for additional personnel. You will be working with an experienced team that has a wealth of knowledge in leadership roles.
Prior medical device experience is highly regarded.
Key Responsibilities:
- Developing and implementing solutions to sustain and improve the Quality Management System (QMS).
- Maintaining and supporting compliance to ISO standards.
- Interfacing with customers on new products, quality issues, and process qualifications.
- Developing and implementing process control programs to ensure customer requirements are met.
- Conducting process validations and qualifications on products.
- Providing manufacturing support and quality expertise related to manufacturing issues and product disposition.
- Performing quality engineering analysis to identify strategies to prevent quality non-conformances and minimize risk.
- Coordinating Non-Conformance Reports (NCR) / Corrective Action Preventive Actions (CAPA) processes to ensure timely resolution and closure of issues.
- Leading training activities on quality procedures, such as compliance, Good Manufacturing Practice (GMP), audit preparation, and Good Distribution Practice (GDP).
- Supporting and representing the site during external audits and conducting internal audits.
- Trending and tracking quality data to support quality improvements across the business.
- Supporting Environmental, Health, and Safety requirements, training, and regulations.
Qualifications & Key Attributes
- Third-level qualification in Engineering, Polymer Science, or equivalent manufacturing experience.
- Experience in statistical analysis (Minitab), Statistical Process Control (SPC), and validations.
- Excellent interpersonal, communication, influencing, and facilitation skills.