
Senior Quality Assurance Professional
3 days ago
This is a 23-month fixed-term contract based at our Carrigtwohill location.
Responsibilities:
- Provide quality engineering support in quality assurance, control, and preventative activities with a focus on continuous improvement of internal products and processes.
- Support supplier quality issues impacting daily operations.
- Advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers.
Key Requirements:
- Work closely with operations and business functions to ensure quality performance of product and processes.
- Collaborate with Divisional QA, cross-functional teams, and suppliers to address top-quality issues.
- Own identified internal and supplier non-conformances and manage the timely closure of NCs.
- Own or support identified internal CAPAs and manage to timely root cause investigation, implementation, and closure.
Essential Skills:
- Experience in interacting with regulatory agencies desired.
- Understanding of US and International Medical Device Regulations.
- Familiarity with ISO 13485, GDP, GMP required.
The ideal candidate will possess strong communication, project management, and influencing skills as well as the ability to manage multiple tasks simultaneously. They will also have strong interpersonal skills, written, oral communication, and negotiation skills. A highly developed problem-solving skillset and strong analytical skills are also essential.
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