Director Operational Excellence (MedTech)

TL;DR

Director Operational Excellence (MedTech): Driving and deploying quality operational excellence practices and standardized quality lifecycle methodologies to deliver compliant and sustainable quality outcomes with an accent on process robustness and inspection readiness. Focus on strengthening end-to-end quality processes and implementing data-driven continuous improvement in a regulated medical device environment.

Location: Wayne, NJ, US

Salary: $210,000 – $250,000 plus 30% bonus

Company

hirify.global provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows across intensive care, cardiovascular procedures, and sterile reprocessing.

What you will do

• Lead the development and implementation of Quality Operational Excellence methodologies, including Lean Quality and risk-based thinking, across all sites.
• Optimize end-to-end quality processes such as CAPA, complaints, audits, change management, and supplier quality.
• Define and monitor quality performance metrics and KPIs to ensure transparency and drive proactive decision-making.
• Train and mentor quality leaders and local teams to foster a culture of accountability and high performance.
• Champion change management and global communication to align stakeholders with the enterprise quality strategy.
• Provide subject matter expertise and leadership during audits, regulatory interactions, and risk mitigation activities.

Requirements

• Master’s Degree in Business Administration, Quality Management, or a related science discipline.
• Minimum 10 years of experience in the medical device, Life Science, or MedTech field.
• Minimum 7 years of experience in data analytics and process optimization within a business or technology environment.
• Strong proficiency in Quality Management System (QMS) operations, ISO standards, and global regulatory requirements.
• Proficiency in data analytics platforms such as Power BI, Tableau, and SQL.
• Must be located in or authorized to work in Wayne, NJ, US

Nice to have

• Certifications in Six Sigma, LEAN, or ASQ Certified Quality Analyst.
• Relevant certifications in artificial intelligence, machine learning, or data analytics.

Culture & Benefits

• Comprehensive health, dental, and vision insurance benefits.
• 401k plan with company match.
• Paid Time Off, parental, and caregiver leave.
• Tuition reimbursement and wellness initiative resources.
• Health and Dependent Care Flexible Spending Accounts and commuter benefits.