Quality Engineer
Medical Device
Longford/Roscommon
CPL Recruitment is assisting our valued client in sourcing a quality engineer to join their team. The site has undergone major investment and expansion, creating this opportunity. You will work with a friendly and experienced team with strong leadership. There are currently two open roles, suitable for candidates from a quality technician level wanting to step up, as well as more experienced candidates with 3-5 years of experience.
Prior medical device experience would be highly regarded.
Key Responsibilities:
1. Developing and implementing solutions to sustain and improve the QMS.
2. Maintaining and supporting compliance with ISO 13485 and ISO 14001 standards.
3. Interfacing with customers on new products, quality issues, and process qualifications.
4. Developing and implementing process control programs to meet customer requirements.
5. Carrying out process validations and product qualifications.
6. Providing manufacturing support and quality expertise related to manufacturing issues and product disposition.
7. Performing quality engineering analysis to identify strategies to prevent non-conformances and minimize risks.
8. Coordinating NCR / CAPA processes to ensure timely resolution and closure of issues.
9. Leading training activities on quality procedures, including compliance, GMP, audit preparation, and GDP.
10. Supporting and representing the site during external audits and conducting internal audits.
11. Trending and tracking quality data to support quality improvements.
12. Supporting environmental, health, and safety requirements, training, and regulations.
13. Performing additional duties as requested by the supervisor.
Qualifications & Key Attributes:
1. Third-level qualification in engineering, polymer science, or equivalent manufacturing experience.
2. Experience in statistical analysis (Minitab), SPC, and validations.
3. Excellent interpersonal, communication, influencing, and facilitation skills.
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