Job ID: JOB-11492
Quality Workstream Lead

Our client a leading MNC located in Galway is recruiting for a Quality Workstream Lead to join their team.This role is commutale from Mayo and Clare too. In this role you will direct a team of quality and design assurance professionals to support the introduction of a new technology that involves collaboration with a multi-functional team. The primary responsibility of the role is to coordinate the activities of the QA/DA team to ensure that all design and quality deliverables are executed on time/on budget per project goals. You will also work very closely with PMO, R&D, Operations to define the critical quality inputs/outputs and ensure they are aligned with the overall project plan objectives across all phases.

Responsibilities and Duties

• Leads QA/DA team members to meet/exceed new product introduction deliverables.
• Promotes awareness of regulatory and customer requirements across all functions.
• Ensures design quality deliverables are clearly defined and aligned with the project team.
• Develops quality strategy and plan that includes all quality inputs/outputs across the lifecycle of the project.
• Manages design controls for project including design verification and validation planning.
• Develops Master Validation Plan for new product introductions.
• Develops appropriate QC test plans internally and with selected Suppliers.
• Establishes robust test methods for components and final product configuration.
• Executes Supplier qualification strategy and process including Vendor audits and quality agreements.
• Primary quality contact for all quality issues, escalations, and presents regular Quality updates to the Executive Leadership team on the status/progress of Quality Plan.

Requirements

• Primary Degree level qualification in Science, Engineering or Technology, plus 10 years in Quality Leadership role in a regulated environment (ISO13485/ FDA).
• Strong technical capability – experience within electronics/medical devices industry and knowledge of NFC manufacture would be an advantage.
• Proven track record in getting results through people and ability to manage across a diverse cultural environment.
• Effective communication skills to support virtual project requirements.
• Strong interpersonal skills to influence many diverse internal and external stakeholders.
• Experience managing in an environment with changing priorities and making appropriate risk based decisions in the face of uncertainty.
• Ability to present complex technical information to Senior leadership.
• 10 years experience in QA or equivalent Technical leadership role.

For more information on this Quality Workstream Lead role in Galway please contact Caroline Kingston on 086 8395531 caroline@hero.ie

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Caroline Kingston

JOB-11492