Global Validation Lead - Medical Devices

Inova Group

Connacht

On-site

EUR 90,000 - 120,000

Full time

4 days ago
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Job summary

Inova Group, on behalf of a global medical device manufacturer in Co. Mayo, seeks a Validation Supervisor to lead a site-based team of Validation Quality Engineers.

You will plan, coordinate and execute equipment and process validations to support new product introductions, change controls and strategic initiatives, ensuring alignment with the Quality Management System. The role requires collaboration with Design Assurance, Engineering and Quality, strong leadership, and a track record in

Qualifications

  • Bachelor's degree in Engineering, Science or a related discipline or equivalent experience.
  • Desirable: CQE or equivalent professional certification.

Responsibilities

  • Lead and supervise a team of Validation Quality Engineers, providing coaching, mentoring and performance guidance.
  • Plan and coordinate equipment, process and test method validations supporting new product development, change control and strategic initiatives.
  • Ensure validation activities follow internal procedures, regulatory requirements and industry best practice.
  • Review and approve validation documentation, including validation plans, risk assessments, protocols, reports and deviation or exception documentation.
  • Allocate resources and manage timelines to support project schedules and operational priorities.
  • Act as site validation liaison with Design Assurance, R&D, Engineering, Manufacturing Operations, Supply Chain and Quality.
  • Support compliance activities, including internal audits, inspections and CAPA processes.
  • Identify and drive continuous improvement in validation processes, standard work and compliance practices.
  • Communicate complex technical information clearly to diverse stakeholders, including senior leadership.
  • Manage multiple priorities and deadlines in a fast-paced, regulated manufacturing environment.

Skills

Leadership
Coaching
Problem solving
Risk-based decision-making
Communication

Education

Bachelor's degree in Engineering, Science or related
Advanced degree (desirable)

Job description

Inova Group, on behalf of a global medical device manufacturer in Co. Mayo, seeks a Validation Supervisor to lead a site-based team of Validation Quality Engineers.

You will plan, coordinate and execute equipment and process validations to support new product introductions, change controls and strategic initiatives, ensuring alignment with the Quality Management System. The role requires collaboration with Design Assurance, Engineering and Quality, strong leadership, and a track record in

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