Our client, a medical device company in Galway are currently looking to recruit a Senior Quality Engineer for their site.
Demonstrates commitment to the Quality Policy (patient safety and product quality) through their daily execution of sound quality practices and the maintenance of an effective quality system. Understands and complies with all the regulations governing the quality systems. Ensures their direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.
- Ensure compliance to all applicable regulatory standards and current GMP procedures and practices.
- Supervision of staff and laboratory engaged in the receipt and disinfection of returned product samples
- Coaches technicians and engineers in performing analysis and root cause investigation on returned product samples
- Completion and approval of investigation records within the Global Complaints System (GCS2) database
- Preparation and delivery of complaint trend data at the monthly value stream Complaint Review Board meetings, site Management Review and divisional Complaint Reviews
- Coaching technicians and engineers in Problem solving and continuous improvement investigations.
- To provide assistance and support to the Quality Engineering function, Complaint Management Centres and EMI Partners
- Provision of excellent service to all internal customers of the Complaint Investigation Site.
- Good interpersonal skills and organizational skills.
- Excellent attention to detail.
- Communicates any concerns about work process regarding environmental impact, health or safety issues to their Manager.
- A Bachelor (Hetac level 8) of Engineering, Sciences or equivalent experience with a minimum of 8 years? experience in a healthcare environment.
- 5-8 years? experience in the Medial Device, Pharma or Food environment.
- Vaccination for Hepatitis B will be required but is not a pre-requisite.
- Experience with new product introduction
- Team player with strong work ethic and positive mentality
- Strong written & verbal communication skills, with excellent stakeholder management.
- Strong technical knowledge & understanding of product design.
- People management experience is an advantage
For further information on this Senior Quality Engineer role in Galway please contact Cliona O?Malley on 091730022 / firstname.lastname@example.org
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