Quality Manager - Medical Device

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

A leading manufacturing organisation is seeking an experienced Quality Manager to join its site leadership team. This is a senior quality leadership position within a highly regulated manufacturing environment where you will lead the Quality function on site and play a key role in driving compliance, operational excellence and continuous improvement.

As Quality Manager, you will:

• You will be responsible for ensuring the site maintains robust Quality Management Systems, regulatory compliance and a strong quality culture while supporting the achievement of strategic business objectives.
• 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 Quality System Regulations, 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.

You will bring: -

• Degree in Engineering, Science or a related discipline.
• Circa 5 to 8 years' quality leadership experience within medical devices or similar
• Have worked in a regulated manufacturing environment.
• Strong knowledge of Quality Management Systems and regulatory compliance.
• Experience operating within ISO 13485 and FDA regulated environments.
• Proven experience leading quality teams and driving performance.
• Strong problem solving and root cause analysis capability.
• Excellent stakeholder management and communication skills.
• Master's degree or further relevant qualifications.
• Six Sigma or Continuous Improvement methodologies.
• Certified Quality Auditor qualification.
• Knowledge of ISO 14971.
• Experience supporting regulatory and customer audits.

What's on Offer

• A senior leadership position, a competitive salary and benefits package.