Director Operational Excellence

Director Operational Excellence

Location: Wayne, NJ, US

Job Overview

Drive and deploy best‑in‑class quality operational excellence practices and standardized quality lifecycle methodologies to deliver compliant, efficient, and sustainable quality outcomes across the organization. This role supports enterprise quality strategy by strengthening process robustness, inspection readiness, and continuous improvement in a regulated medical device environment.

Key Duties and Responsibilities

• Lead the development, implementation, and standardization of Quality Operational Excellence methodologies (e.g., Lean Quality, problem solving, risk‑based thinking, continuous improvement) across all sites and functions, fostering a culture of compliance, accountability, and high performance.
• Support the continuous improvement of end‑to‑end quality processes (e.g., CAPA, complaints, audits, change management, risk management, supplier quality) to ensure timely, compliant, and effective execution.
• Facilitate cross‑functional teams in mapping quality processes, identifying inefficiencies, compliance risks, and improvement opportunities, and executing sustainable improvements using data‑driven and risk‑based approaches.
• Define, monitor, and continuously improve quality performance metrics and KPIs, ensuring transparency, regular reporting, and feedback loops to drive proactive decision‑making and continual improvement.
• Train, mentor, and coach quality leaders and local teams on operational excellence tools and behaviors, enabling ownership at the site and functional level and building autonomous, high‑performing quality teams.
• Champion change management and communication activities to align stakeholders globally, ensuring quality strategy is clearly translated into day‑to‑day execution and behaviors.
• Provide subject matter expertise and leadership support for audits, inspections, regulatory interactions, and risk mitigation activities, ensuring alignment with internal quality standards and external regulatory requirements.
• Capture, share, and scale best practices and lessons learned across sites and business units, enabling rapid deployment of proven quality excellence models.
• Develop and strengthen a network of Quality Operational Excellence Champions across business areas and production areas to embed continuous improvement capabilities locally.

Quality System Duties and Responsibilities

• Build quality into all aspects of work by maintaining compliance with applicable quality system requirements, regulatory standards, and company policies.
• Act as a role model for quality mindset, ethical behavior, and patient safety focus across the organization.

Qualifications

• Master’s Degree in a relevant field (e.g., Business Administration, Quality Management, or other related science discipline) or equivalent combination of education and experience.
• A minimum of 10 years’ experience in the medical device, Life Science or MedTech field.
• Strong understanding of Quality Management System operations and application of the Regulations, ISO standards, and management controls.
• Relevant certifications in data analytics, artificial intelligence, machine learning, or regulatory compliance (e.g., Six Sigma, LEAN, ASQ Certified Quality Analyst) are highly desirable.
• Minimum 7 years of experience in data analytics and process optimization in a business or technology environment.

Required Knowledge, Skills and Abilities

• Proficiency in data analytics platforms (e.g., Power BI, Tableau, SQL).
• Strong understanding of global regulatory requirements and risk management principles.
• Excellent collaboration, communication, and stakeholder management skills.
• Exceptional problem‑solving and project management skills with a focus on compliance, efficiency, and continuous improvement.

Salary range: $210k – $250k plus bonus of 30%

Benefits

• Health, Dental, and Vision insurance benefits
• 401k plan with company match
• Paid Time Off
• Wellness initiative & Health Assistance Resources
• Life Insurance
• Short and Long Term Disability Benefits
• Health and Dependent Care Flexible Spending Accounts
• Parental and Caregiver Leave
• Tuition Reimbursement

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

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