Global Validation Lead - Quality & Compliance (MedTech)

Hollister Incorporated; Ballina Municipal District (2014-2019); Remote; EUR 90,000 - 120,000; Full time

Job summary

Hollister Incorporated in Ballina, Ireland, 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 control, and strategic initiatives under the Quality Management System.

You will partner with Design Assurance, Engineering, Manufacturing, and Quality teams to ensure compliance with regulatory standards such as ISO 13485 and FDA regulations,

Qualifications

• Bachelor’s degree in Engineering, Science, or a related discipline, or equivalent experience.
• Certified Quality Engineer (CQE) or equivalent.
• Advanced degree in a technical or scientific discipline.

Responsibilities

• Lead and supervise a team of Validation Quality Engineers with coaching and performance guidance.
• Plan and coordinate equipment, process, and test method validations for new product development and change control.
• Ensure validation activities comply with internal procedures and regulatory requirements.
• Review and approve validation documentation including plans, risk assessments, and reports.
• Allocate resources and manage timelines to support project schedules.
• Act as site validation liaison with Design Assurance, R&D, Engineering, Manufacturing, Supply Chain, and Quality.
• Support audits, inspections, and CAPA processes.

Skills

Leadership

Regulatory knowledge

Quality engineering

Validation planning

Statistical analysis

Education

Bachelor’s degree in Engineering/Science

CQE certification

Advanced degree in a technical field

Job description

Hollister Incorporated in Ballina, Ireland, 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 control, and strategic initiatives under the Quality Management System.

You will partner with Design Assurance, Engineering, Manufacturing, and Quality teams to ensure compliance with regulatory standards such as ISO 13485 and FDA regulations,