Director Operational Excellence

Getinge•Wayne, NJ

About The Position

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.

Requirements

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 is required).
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.
Minimum 7 years of experience in data analytics and process optimization in a business or technology environment.
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.

Nice To Haves

Relevant certifications in data analytics, artificial intelligence, machine learning, or regulatory compliance (e.g., Six Sigma, LEAN, ASQ Certified Quality Analyst) are highly desirable.

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.
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.