Principal Global Process Owner – Quality Improvement

About This Opportunity

We are representing a confidential medical device manufacturing organization seeking a Principal Global Process Owner - Quality Improvement based in Ireland. This is a remote position with flexibility required to align with global business needs.

Our client operates a multi-site global manufacturing network and is building out their centralized quality systems team. This role will own end-to-end process leadership for critical quality improvement subprocesses across all facilities, establishing global standards and driving measurable compliance and performance outcomes.

Responsibilities

• Serve as the single global design authority and subject matter expert for assigned quality improvement subprocesses across all manufacturing sites
• Define, control, and manage global process standards with authority to mandate procedural changes and system-level corrective actions
• Monitor process performance using KPIs and trigger interventions where compliance or performance gaps exist
• Ensure alignment with regulatory requirements including FDA 21 CFR, EU MDR, and ISO 13485 standards
• Lead cross-functional project teams to achieve quality system milestones and business objectives
• Act as business owner for digital quality workflows, partnering with IT to prioritize enhancements and ensure data integrity
• Lead the global community of quality users and stakeholders to drive adoption of standard processes and best practices through coaching and workshops
• Take ownership of systemic corrective actions arising from audits, ensuring sustainable fixes across impacted sites
• Support customer and regulatory audits at global facilities as required
• Deliver quantifiable cost-of-quality and efficiency improvements through targeted process changes

What We're Looking For

Experience and Education:

• 8-15+ years of quality systems experience in a manufacturing environment, preferably medical devices
• Proven track record leading enterprise-wide quality transformations in multi-site operations
• Bachelor's degree in engineering, life sciences, or related technical field required; Master's or Doctorate preferred
• Lean Six Sigma certification or equivalent is highly desirable

Technical Expertise:

• Deep knowledge of FDA QSR, EU MDR, ISO 13485, and other medical device regulations
• Strong understanding of Quality Management System processes and global quality operations
• Proficiency in root cause analysis methodologies and quality tools
• Experience with process mapping, data analytics, and continuous improvement frameworks
• Ability to query quality systems, conduct data analysis, and communicate findings to drive business decisions

Leadership and Soft Skills:

• Exceptional communication, facilitation, and stakeholder influence skills across diverse teams and cultures
• Proven change leadership with ability to achieve alignment in matrixed, cross-functional environments
• Strong business acumen with understanding of how quality processes impact financials and operations
• Demonstrated ability to manage complex global projects with multiple workstreams
• Continuous improvement mindset with strong drive to overcome challenges and deliver results
• Proficiency in leveraging technology solutions to optimize quality processes

How We Work with You

Get A Job.ai is managing this confidential search on behalf of our client. When you apply through our platform, one of our specialized recruiters will review your background and conduct an initial screening. If there's a strong match, we will submit your profile to the client for consideration and guide you through each stage of their interview process.

Important: Please do not attempt to contact the client directly. All communication and coordination will be managed through Get A Job.ai to ensure a professional and confidential process.

Pay

Compensation details will be discussed with qualified candidates during the screening process.

Equal Opportunity: Get A Job.ai is committed to inclusive hiring practices. We encourage applications from all qualified candidates regardless of background, and we actively support veterans and individuals with disabilities in their job search.