Quality Manager - Job Opportunity at Edwards Lifesciences

Limerick, Ireland
Full-time
Senior
Posted: April 1, 2025
On-site
EUR 75,000 - 95,000 annually based on Limerick market conditions and role seniority

Benefits

Medical device industry exposure
Career development opportunities
Quality systems expertise development
Leadership role in regulated environment
Project management experience

Key Responsibilities

Lead quality system implementation and maintenance for medical device manufacturing
Direct and mentor quality engineering teams
Drive continuous improvement initiatives
Manage risk assessment and quality planning activities
Oversee validation and qualification processes
Interface with regulatory bodies and internal stakeholders
Guide product lifecycle quality management

Requirements

Education

Bachelor's Degree required, Master's Degree preferred in related field

Experience

Previous related experience required, regulated industry experience preferred

Required Skills

Project management leadership Microsoft Office Suite proficiency Problem-solving and analytical skills Written and verbal communication Quality Engineering procedures knowledge Team management and coaching Metrics development and integration Professional interaction across organizational levels Adaptability to fast-paced environment
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Sauge AI Market Intelligence

Industry Trends

Medical device quality requirements are becoming increasingly stringent with new EU MDR regulations driving demand for experienced quality professionals Integration of digital quality management systems is creating need for technology-savvy quality leaders Rising focus on post-market surveillance requiring enhanced risk management capabilities

Role Significance

Typically manages 5-10 direct reports including Quality Engineers and Technicians in medical device manufacturing environment
Senior management position with direct influence on product quality and regulatory compliance, reporting to Quality Director or Site Head

Key Projects

Quality Management System optimization and digitalization initiatives New product introduction quality planning Regulatory compliance programs Supplier quality management system development Quality metrics and KPI implementation

Success Factors

Strong understanding of medical device regulations and quality system requirements Ability to balance quality requirements with operational efficiency Excellence in team leadership and cross-functional collaboration Strategic thinking in risk management and quality planning

Market Demand

High demand with significant growth projected due to expanding medical device sector in Ireland and increasing regulatory requirements

Important Skills

Critical Skills

Quality system management expertise - essential for maintaining regulatory compliance Leadership and team development - critical for driving quality culture Risk management proficiency - fundamental for medical device industry Technical understanding of manufacturing processes - necessary for effective quality oversight

Beneficial Skills

Project management certification Six Sigma methodology knowledge Digital quality management systems expertise Industry 4.0 understanding for future quality systems evolution

Unique Aspects

Direct impact on life-saving medical devices
Exposure to cutting-edge medical technology
Complex regulatory environment requiring high expertise
Strong career growth potential in expanding medical device sector

Career Growth

2-4 years in role before advancement, depending on business growth and performance

Potential Next Roles

Quality Director Site Quality Head Global Quality Systems Leader Regulatory Affairs Director

Company Overview

Edwards Lifesciences

Edwards Lifesciences is a global leader in patient-focused medical innovations for structural heart disease and critical care monitoring

Leading position in heart valve technology with strong market presence in critical care devices
Limerick facility serves as strategic manufacturing hub for European market
Innovation-driven environment with strong focus on patient outcomes and quality excellence
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