Quality Engineer
Medical Device
CPL Recruitment is assisting our client in sourcing two quality engineers to join their team. The site has undergone significant investment and expansion, requiring the need for these roles. You will work with a friendly and experienced team that has a wealth of experience in leadership positions.
The ideal candidate will have a background in quality engineering or a related field, with prior medical device experience highly regarded.
Key Responsibilities:
•Developing and implementing solutions to sustain and improve the quality management system (QMS).
•Maintaining and supporting compliance to ISO standards.
•Interface 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 qualifications on products.
•Providing manufacturing support and quality expertise on 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, such as compliance, GMP, audit preparation, and GDP.
•Supporting and representing the site during external audits and conducting internal audits.
•Tracking and trending quality data to support quality improvements across the business.
•Supporting environmental, health, and safety requirements, training, and regulations.
•Performing additional duties as requested by the direct supervisor.
Qualifications & Key Attributes:
•Third-level qualification in engineering, polymer science, or equivalent manufacturing experience.
•Experience in statistical analysis (Minitab), SPC, and validations.
•Excellent interpersonal, communication, influencing, and facilitation skills.