On behalf of our client, a multinational medical devices company, we're looking for a
Quality System Specialist
Main duties:
Quality Systems Complaints / CAPA / NCRs
- Manage the recording, investigation and resolution of product complaints, product problems, or safety issues
- Coordinate and maintain the Corrective Action Program to assure appropriate investigation and implementation
- Run regular Complaint, CAPA, NCR and continuous improvement monitoring meeting
- Generate KPI data around Complaint, CAPA, NCR and continuous improvement
Validation support
- Provide support to the Quality Engineering and Operations functions including Risk Assessment reviews and updates
- Ensures that all deviations to protocols and/or deviations to acceptance criteria are adequately controlled, documented and addressed by the Validation Project Team
Environmental and testing
- Co-ordinate the environmental monitoring activities of the contractors
- Manage in process bioburden / Microbial ID monitoring
- Ensure all environmental metrics are maintained up to date
Regulatory Affairs Support
- Provide support with all international country submissions
- Provide support to solve and reply to any regulatory query
- Help to manage and maintain all documentation including Technical Master File
Operational Support
- Support the preparation of change notifications/Validation protocols and Reports
- Support sterilisation validation / revalidisation
- Provide ongoing manufacture support to help the team meet its business objectives
- Provide Quality role in new product introduction and transfers to production
- Customer service - Internal: Develop harmonious working relationships with all functions, and ensure employees have the necessary information (data analysis) and resources to effectively perform their jobs
Main requirements:
- Experience in working in High Volume Production Facility
- Strong computer skills - Change control management; design, process and system.
- Familiarity with ISO quality systems ( ISO13485 – 21 CFR 820)
- Good customer relation skills
- Ability to present an independent opinion
- Good communication and interpersonal skills -communicate highly technical information, both verbally and in writing, to both non-technical and technical associates
- Quality of work / Attention to detail; maintains high standards despite pressing deadlines
- Problem Solving (using recognised tools) and decision making (makes sound factual decisions)
- Risk Management including FMEA generation
What is offered:
- Competitive salary
- Job location in Ireland
- Working in an international environment