Senior Quality Leader — Medical Devices

Sanderson; Leinster; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Competitive salary and benefits

Job summary

Sanderson is seeking an experienced Quality Manager to lead the Quality function on site within a highly regulated manufacturing environment. You will drive compliance, operational excellence and continuous improvement as a member of the site leadership team.

The role focuses on maintaining robust QMS, regulatory compliance, and a strong quality culture, while mentoring the Quality team and defining the quality strategy to meet strategic objectives.

Qualifications

• Senior-quality leadership experience in regulated manufacturing.
• ISO 13485 and FDA requirements experience.
• Strong root cause analysis capability.

Responsibilities

• Maintain QMS, regulatory compliance and a quality culture on site.
• Lead, develop and mentor the site Quality team.
• Define and implement the site's quality strategy and improvement plans.
• Maintain and continuously improve the Quality Management System.
• Ensure compliance with ISO 13485, FDA QSR, GMP and customer requirements.
• Manage quality budgets and reduce quality related risk and cost.
• Act as site Management Representative and lead Management Review activities.
• Drive CAPA processes and root cause investigations.
• Oversee customer complaints and quality issue resolution.
• Lead internal audit programmes and support external audits.
• Ensure effective change control processes are maintained.
• Develop and report quality KPIs, trends and performance metrics.
• Drive continuous improvement initiatives across the site.
• Promote a strong quality first culture throughout the organisation.
• Support the wider leadership team in achieving operational and strategic goals.

Skills

Quality leadership

Problem solving

Stakeholder management

Communication skills

Regulatory knowledge

Regulatory compliance

Six Sigma

Continuous Improvement

Auditing

Quality Auditor

Education

Degree in Engineering, Science or related

Master's degree or higher

Six Sigma certification

Job description

Sanderson is seeking an experienced Quality Manager to lead the Quality function on site within a highly regulated manufacturing environment. You will drive compliance, operational excellence and continuous improvement as a member of the site leadership team.

The role focuses on maintaining robust QMS, regulatory compliance, and a strong quality culture, while mentoring the Quality team and defining the quality strategy to meet strategic objectives.