Principal Global Process Owner – Quality Improvement

Job not on LinkedIn

🔥 5 minutes ago

🇮🇪 Ireland – Remote

⏰ Full Time

🔴 Lead

✨ Principal

👻 Ghost score 10%

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Integer Holdings Corporation

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1970

🏥 Healthcare

🏭 Manufacturing

⚕️ Healthcare Insurance

💰 Post-IPO Debt on 2023-01

Healthcare • Manufacturing • Healthcare Insurance

Integer Holdings Corporation is a leading provider of advanced medical device outsourcing services. With a rich history of 80 years, Integer specializes in the design, development, and manufacturing of medical devices and components. It serves major global OEMs by offering a wide range of products such as finished device systems, Class III Medical Devices, and components for cardiac rhythm management, neuromodulation, and vascular health markets. Integer is renowned for its manufacturing excellence, innovation, and commitment to enhancing patient lives through high-quality medical solutions. The company operates globally, providing unique design expertise, comprehensive product development, and strategic partnerships in the medical device industry.

📋 Description

• Own the assigned Integer Quality Management System (IQMS) subprocess end to end • Define global standards, govern process execution, enable digital workflows, and deliver tools and processes for sustained performance • Exercise decision authority over global process standards, procedural changes, and system-level corrective actions • Lead an empowered user community and establish decision rights • Ensure regulatory compliance and audit readiness • Serve as subject matter expert and global design authority for standard definition, control, and change management • Monitor process performance across sites using KPIs • Trigger corrective actions, standard work updates, and targeted interventions when gaps exist • Lead cross-functional project teams to achieve milestones and objectives • Align processes with FDA 21 CFR, EU MDR, ISO 13485, customer expectations, and internal quality standards • Lead periodic reviews and updates of procedures and training materials • Own digital workflows and system capabilities, partnering with IT on enhancements and data integrity • Lead users and stakeholders to drive adoption of standard processes and best practices • Use coaching, workshops, and targeted interventions • Facilitate collaboration to resolve systemic issues and enhance product quality • Set aligned goals and objectives as a key opinion leader • Own systemic corrective actions arising from audits • Champion best practices across sites to reduce variability and improve efficiency • Support customer and regulatory audits at Integer sites • Reduce process variability and site-to-site deviations • Improve audit outcomes, data continuity, cost of quality, and efficiency • Nurture an engaged subprocess community and deliver defined goals and milestones

🎯 Requirements

• Technically renowned subject matter expert, typically earned through 8–15+ years of experience in a manufacturing environment, preferably medical devices • Proven track record leading enterprise-wide transformations • Bachelor’s degree in engineering, life sciences, or related technical field highly recommended, not required • Master’s degree or Doctorate preferred • Lean Six Sigma certification or equivalent desirable • Knowledge of domestic and international regulations and industry standards, including FDA QSR, EU MDR, and ISO 13485 • Strong knowledge of Quality Management System processes • Experience with global quality systems and multi-site operations • Proficiency in root cause analysis methodologies and quality tools • Ability to influence and drive change across diverse teams and cultures • Ability to query systems, conduct data analysis, and communicate results promptly • Expertise in process mapping, analytics, and continuous improvement • Proven change leadership in matrixed and cross-functional environments • Communication, influencing, and negotiation capabilities • Understanding of how quality processes impact financials and operations • Ability to manage complex projects and coordinate global rollouts with multiple workstreams • Familiarity with governance, compliance, and industry-specific regulations • Proficiency in leveraging technology solutions • Ability to flex schedule in line with business needs • Ability to work remotely from Ireland