Principal Global Process Owner – Quality Improvement

This is a fully remote position, open to applicants in Ireland.

📋 Description

• Take full ownership of the designated Integer Quality Management System (IQMS) subprocess from start to finish.

• Establish global standards, oversee process execution, facilitate digital workflows, and provide tools and processes to ensure ongoing performance.

• Exercise decision-making authority regarding global process standards, procedural modifications, and system-level corrective measures.

• Lead a proactive user community and define decision-making rights.

• Ensure adherence to regulatory requirements and maintain readiness for audits.

• Act as a subject matter expert and global design authority for standard definition, control, and change management.

• Monitor process performance across various sites utilizing key performance indicators (KPIs).

• Initiate corrective actions, update standard work, and implement targeted interventions when deficiencies are identified.

• Lead cross-functional project teams to meet milestones and objectives.

• Align processes with FDA 21 CFR, EU MDR, ISO 13485, customer expectations, and internal quality standards.

• Conduct regular reviews and updates of procedures and training materials.

• Manage digital workflows and system capabilities, collaborating with IT on enhancements and ensuring data integrity.

• Guide users and stakeholders to promote the adoption of standard processes and best practices.

• Utilize coaching, workshops, and targeted interventions effectively.

• Foster collaboration to address systemic issues and improve product quality.

• Establish aligned goals and objectives as a recognized opinion leader.

• Oversee systemic corrective actions resulting from audits.

• Advocate for best practices across sites to minimize variability and enhance efficiency.

• Assist in customer and regulatory audits at Integer locations.

• Aim to reduce process variability and discrepancies between sites.

• Enhance audit results, data continuity, cost of quality, and overall efficiency.

• Cultivate an engaged subprocess community and achieve defined goals and milestones.

⛳️ Requirements

• Recognized subject matter expert with 8–15+ years of experience in a manufacturing environment, ideally within medical devices.

• Demonstrated success in leading enterprise-wide transformations.

• A bachelor's degree in engineering, life sciences, or a related technical field is highly recommended but not mandatory.

• A master’s degree or doctorate is preferred.

• Lean Six Sigma certification or equivalent is desirable.

• Familiarity with domestic and international regulations and industry standards, including FDA QSR, EU MDR, and ISO 13485.

• Strong understanding of Quality Management System processes.

• Experience with global quality systems and operations across multiple sites.

• Proficient in root cause analysis methodologies and quality tools.

• Capable of influencing and driving change within diverse teams and cultures.

• Skilled in querying systems, performing data analysis, and effectively communicating results.

• Expertise in process mapping, analytics, and continuous improvement.

• Proven leadership in change management within matrixed and cross-functional settings.

• Strong communication, influencing, and negotiation skills.

• Understanding of the impact of quality processes on financials and operations.

• Ability to manage complex projects and coordinate global rollouts involving multiple workstreams.

• Knowledgeable about governance, compliance, and industry-specific regulations.

• Proficient in utilizing technology solutions.

• Flexible schedule to meet business needs.

• Able to work remotely from Ireland.

🏝️ Benefits

• Comprehensive health and wellness programs.

• Competitive salary and performance-based bonuses.

• Opportunities for professional development and continuous learning.

• Collaborative and inclusive work environment.

• Flexible working arrangements.