Operations Lead, Medical Devices & ISO 13485

Tech Skills Resources (part of the CPL Group); Limerick; On-site; EUR 70,000 - 100,000; Full time

Job summary

Tech Skills Resources (part of the CPL Group) is supporting an established healthcare and pharmacy supplies company in Limerick to hire an experienced Operations Manager. This role leads daily operations in a regulated medical device environment, focusing on safety, quality, delivery, and cost objectives.

The successful candidate will drive continuous improvement, develop KPIs, and collaborate with Quality and Regulatory teams to maintain audit readiness.

Qualifications

• Significant operations management experience in medical devices or regulated life sciences.
• Experience in ISO 13485 quality management systems.
• Proven ability to develop operational teams and drive performance improvements.
• Experience in change management and organisational transformation.
• Strong leadership and people management abilities.
• Excellent communication and problem-solving skills.

Responsibilities

• Oversee daily operations, ensuring safety, quality, service, cost and delivery objectives are met.
• Ensure ISO 13485 and regulatory requirements are followed and audit readiness maintained.
• Collaborate with Quality and Regulatory teams to support audits and compliance.
• Drive operational excellence through performance management and continuous improvement.
• Develop KPIs and management information to monitor performance.
• Plan resources and workforce according to business needs.
• Foster accountability and continuous improvement across teams.
• Identify opportunities for organisational development and succession planning.
• Support employee growth through coaching and mentorship.
• Collaborate with departments to achieve business goals.
• Identify operational risks and implement mitigation strategies.
• Assist in introducing new products and technologies.

Skills

Operations management

Leadership

Change management

Communication

Problem solving

Regulatory compliance

People management

Safety & quality

Regulated environment

Education

Bachelors degree in a relevant field

Job description

Tech Skills Resources (part of the CPL Group) is supporting an established healthcare and pharmacy supplies company in Limerick to hire an experienced Operations Manager. This role leads daily operations in a regulated medical device environment, focusing on safety, quality, delivery, and cost objectives.

The successful candidate will drive continuous improvement, develop KPIs, and collaborate with Quality and Regulatory teams to maintain audit readiness.