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Quality Systems Specialist

Quality & Laboratory
James Roche
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Job Reference: JO-2109-65965_1631276856


I am working with a leading Medical Device organisation based in Cork that has a 12 month contract opportunity for an experienced Quality Systems specialist to support their manufacturing operation. If you have experience in quality document control, you may be an excellent fit.

This position will support the execution of the Site's Quality Management System Processes and participate in Quality System projects. This person will drive the flawless and compliant execution of the assigned processes to meet customer and business needs while ensuring the processes are in compliance with regulatory requirements.

Key responsibilities

· Manages specified quality system processes.

· Works directly with various customers of the quality system processes to ensure compliance to site, sector/franchise/regulatory requirements.

· Work directly with the various owners/teams to ensure investigations/actions are implemented and accurately documented in a timely manner

· Compiles contextualizes, evaluates and presents Quality Systems data and metrics for all metric review meetings. Utilizes quality tools to track, trend and communicate quality performance metrics in presentations/reports/dashboards.

· Where applicable, conducts internal audits to ensure compliance to regulatory and customer requirements. Responds to and drive/ participates in investigations and corrective action implementation for identified quality issues including internal/external audits actions.

Personal Traits

· Performs other related duties as required. Flexible work ethic

· Excellent communication skills (written and oral).

· Excellent Planning & Organizing Skills

· Extent of Confidentiality - Discretion is essential in view of nature of the business.


· BS Degree in Business, Engineering, or related field. Advanced degree highly desirable as well as knowledge of FDA Regulations/ Third level qualification (Science or an Engineering related discipline)

· Planning and organizing skills

· Excellent PC, interpersonal and influencing skills

· Proficiency in applicable GMP/QSR regulations and in- depth knowledge of Quality Systems

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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James Roche
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