Ballina: Lead Validation Quality Engineer

Hollister Incorporated; Ballina; On-site; EUR 65,000 - 90,000; Full time

Job summary

Hollister Incorporated in Ballina, Ireland, is seeking a Validation Supervisor to lead a team of Validation Quality Engineers. You will plan, coordinate and execute equipment and process validations to support new products and change controls while ensuring compliance with ISO 13485 and FDA standards.

The role requires 8–12 years in validation/quality within regulated manufacturing, a CQE or equivalent certification, and a track record of guiding teams to continuous improvement in a highly

Qualifications

• Bachelor’s degree in Engineering, Science, or related discipline.
• 8–12 years of experience in validation, quality engineering, or related role within a regulated industry.
• Experience in medical device, pharmaceutical, or similarly regulated manufacturing environments.
• Prior experience leading or supervising technical or quality teams.
• Certified Quality Engineer (CQE) or equivalent certification.
• Advanced degree in a technical or scientific discipline is preferred.
• Strong working knowledge of ISO 13485, FDA 21 CFR Parts 820 and 11.
• Experience with statistical analysis and validation tools.
• Experience supporting audits and regulatory inspections.

Responsibilities

• Lead and supervise a team of Validation Quality Engineers.
• Plan and coordinate equipment, process and test method validations.
• Ensure validation activities comply with procedures and regulatory standards.
• Review validation docs: plans, risk assessments, protocols, reports.
• Allocate resources and manage project timelines.
• Act as site validation liaison across Design Assurance, R&D, Engineering, Manufacturing, Supply Chain and Quality.
• Support internal audits and CAPA processes.
• Identify opportunities to improve validation processes and standards.
• Lead validation personnel to deliver objectives.
• Apply problem solving and risk-based decision making in a dynamic environment.
• Communicate complex technical information to senior leadership.
• Collaborate across functions and maintain quality standards.
• Maintain commitment to quality and continuous improvement.

Education

Bachelor’s Degree in Engineering, Science, or related discipline

Job description

Hollister Incorporated in Ballina, Ireland, is seeking a Validation Supervisor to lead a team of Validation Quality Engineers. You will plan, coordinate and execute equipment and process validations to support new products and change controls while ensuring compliance with ISO 13485 and FDA standards.

The role requires 8–12 years in validation/quality within regulated manufacturing, a CQE or equivalent certification, and a track record of guiding teams to continuous improvement in a highly