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Quality Engineer II - Job Opportunity at Integer

New Ross, Ireland
Full-time
Mid-level
Posted: August 6, 2025
On-site
EUR 45,000 - 60,000 annually based on Ireland's competitive life sciences sector, with Integer being a major medical device manufacturer offering above-market compensation for quality roles

Benefits

Comprehensive quality management system training that enhances professional credibility and marketability
Exposure to FDA-regulated environment providing valuable regulatory experience
Cross-functional collaboration opportunities that build leadership and communication skills
Cleanroom and laboratory work experience that is highly valued in life sciences industry
Technical project leadership experience that accelerates career advancement
Mentorship from experienced Life Sciences professionals providing accelerated skill development

Key Responsibilities

Drive quality excellence across medical device manufacturing by embedding quality standards into all operational processes and serving as a quality champion
Lead technical projects in sterilization, environmental monitoring, product cleanliness, and biocompatibility to ensure regulatory compliance and product safety
Author and review critical technical documentation including protocols and reports that support FDA submissions and regulatory approvals
Execute sophisticated data analysis to identify root causes of quality issues and implement corrective actions that prevent future occurrences
Collaborate with cross-functional teams to support Manufacturing Excellence and Market Focused Innovation strategies that drive competitive advantage
Champion continuous improvement initiatives through standardized problem-solving methodologies and 5S workplace organization
Support validation master plans and quality improvement imperatives that directly impact customer satisfaction and market success

Requirements

Education

Bachelor's degree in Biology, Microbiology, or related technical field

Experience

At least 3 years of experience, or 7+ years of relevant experience if education requirements are not met

Required Skills

Solid technical aptitude with ability to be effective contributor to team Competencies in both written and oral communication Ability to work independently as well as collaboratively with other associates and cross functional teams Ability to maintain calm demeanor in high energy, constantly changing product environment Positive, can-do attitude with underlying belief that failure is not an option Standard data analysis practices and techniques Application of microbiological and biocompatibility concepts in medical device manufacturing
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Sauge AI Market Intelligence

Industry Trends

The medical device industry is experiencing unprecedented growth driven by aging populations globally, with the market expected to reach $718 billion by 2030, creating sustained demand for quality engineers with life sciences expertise Regulatory requirements are becoming increasingly stringent worldwide, with FDA and EMA implementing more rigorous quality standards, making experienced quality engineers essential for compliance and market access Digital transformation in medical device manufacturing is driving demand for quality professionals who can integrate traditional quality practices with data analytics and digital quality management systems Post-pandemic emphasis on medical device safety and reliability has elevated the strategic importance of quality engineering roles, with companies investing heavily in quality infrastructure

Role Significance

Typically manages or influences 3-5 direct reports or project team members while collaborating across multiple cross-functional teams of 10-15 professionals
Mid-level position with significant autonomy and technical leadership responsibilities, serving as a bridge between junior quality staff and senior management while driving quality excellence initiatives

Key Projects

Validation of sterilization processes for new medical device products requiring FDA approval Implementation of environmental monitoring systems for cleanroom operations Biocompatibility testing programs for implantable medical devices Root cause analysis investigations for quality deviations with regulatory reporting requirements

Success Factors

Deep understanding of FDA Quality System Regulation (QSR) and ISO 13485 requirements is essential for navigating the complex regulatory landscape of medical device manufacturing Strong analytical and problem-solving capabilities are critical for identifying root causes of quality issues and implementing effective corrective actions that prevent recurrence Excellent communication skills are vital for interfacing with regulatory bodies, cross-functional teams, and senior management while presenting complex technical information clearly Adaptability and resilience are crucial given the fast-paced, high-stakes environment where quality failures can have serious patient safety implications

Market Demand

High demand driven by Ireland's position as a European hub for medical device manufacturing and the critical nature of quality roles in FDA-regulated environments

Important Skills

Critical Skills

Microbiological expertise is essential as contamination control is fundamental to medical device safety, and any failures can result in serious patient harm and regulatory action Data analysis capabilities are crucial for identifying trends, supporting regulatory submissions, and demonstrating statistical control of manufacturing processes to FDA inspectors Technical writing skills are vital for creating validation protocols, investigation reports, and regulatory documentation that must meet strict FDA requirements for clarity and completeness

Beneficial Skills

Project management certification (PMP) would enhance ability to lead complex validation projects with multiple stakeholders and tight regulatory deadlines Six Sigma training would provide advanced statistical tools for quality improvement initiatives and root cause analysis methodologies Regulatory affairs knowledge would create opportunities for broader career development and increased value to the organization

Unique Aspects

Opportunity to work on life-critical medical devices that directly impact patient outcomes, providing meaningful work with societal impact
Exposure to cutting-edge sterilization technologies and biocompatibility testing methods that are at the forefront of medical device innovation
Access to Integer's global network of technical experts and best practices across multiple therapeutic areas and device types
Involvement in FDA interactions and regulatory submissions that provide invaluable experience for career advancement in regulated industries

Career Growth

Progression to senior roles typically occurs within 3-5 years with demonstrated technical excellence and leadership capabilities, with management roles achievable within 5-7 years

Potential Next Roles

Senior Quality Engineer with expanded technical leadership and mentoring responsibilities Quality Manager overseeing quality systems for entire product lines or facilities Regulatory Affairs Manager focusing on FDA submissions and global regulatory strategy Quality Director with P&L responsibility for quality operations across multiple sites

Company Overview

Integer

Integer Holdings Corporation is a leading medical device outsourcing company serving the world's largest medical device manufacturers with revenue exceeding $1.2 billion annually and operations across multiple continents

Integer holds a dominant position in the medical device contract manufacturing market, serving as a critical partner to major OEMs and maintaining strong relationships with regulatory bodies worldwide
The New Ross, Ireland facility represents Integer's strategic European hub, providing access to EU markets while benefiting from Ireland's favorable business environment and skilled workforce in life sciences
Integer fosters a culture of quality excellence and continuous improvement, with strong emphasis on employee development, cross-functional collaboration, and adherence to the highest ethical standards in medical device manufacturing
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