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Senior Quality Specialist (Supervisor) - Medical Devices

Reference:CK/AIKE-741161
Location: Cork
Qualification:Degree
Experience:4-5 Years
Job Type:Permanent
Salary:€50000 - €55000
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Permanent Role

JOB SCOPE:

This position will support the execution of the Site’s Quality Management System Processes and deliver Quality System projects. The successful individual 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. This role will involve liaising with cross functional teams on driving improvement and streamlining of the assigned processes and managing a group of Quality Systems Specialists. The successful candidate will be involved in the achievement of department metrics and targets under the 0-50-100 (Zero Accidents & Defects, 50% Reduction in Lead times, 100% increase in Throughput) Operational Excellence Program as well as supporting key site objectives. Also, support a culture of Continuous Improvement by using Lean Manufacturing tools in a structured approach to problem solving.

KEY RESPONSIBILITIES:

• Manage, coach & develop a team of Quality System Specialists.
• Drives compliant execution of processes and projects.
• 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.
• Understands and uses data, key metrics and statistical methods, quality tools or computer based solutions to improve processes.
• Responsible for identifying and communicating the need for process improvement opportunities to responsible management.
• Identifies personnel that require training on the relevant processes and rolls out training as required.
• Role model company values and site ideal behaviour’s.

SKILLS (5-7 top core skills)

• Ability to work in a diverse and dynamic environment
• Planning and prioritizing activities
• Good communication and interpersonal skills
• Negotiation skills
• Ability to present data effectively
• Problem-solving skills
• Team working skills
• Analytical skills

EDUCATION AND EXPERIENCE

• Third level qualification (preferably Science or an Engineering related discipline) and 5 or more years of related experience
• Knowledge of the applicable regulations and working knowledge of other major regulatory agencies regulations and guidance’s is highly preferred.
• Proficiency with MS Office, including Word, Excel and Power Point, Adobe, SharePoint and ability to quickly learn new systems is required.
• People management experience is an advantage
• Lean or Six Sigma qualifications is an advantage



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