Global Head of Quality Manufacturing Excellence

NIPRO Corporation - Global; North Carolina; On-site; USD 180,000 - 240,000; Full time

Job summary

NIPRO Corporation - Global is seeking a Senior Director of Quality Manufacturing to oversee quality operations across eight manufacturing sites in North and South America. You will drive a world-class quality management system ensuring products, processes, and suppliers meet regulatory and customer expectations.

You will lead QA, Supplier Quality, Incoming Inspection, Production Quality, Validation, and Quality Engineering, shaping a culture of quality, compliance, and continuous improvement

Qualifications

• 15+ years of progressive quality leadership in regulated manufacturing.
• 8+ years leading quality and compliance programs in FDA-regulated environments.
• Experience leading regulatory inspections, notified body audits, customer audits, and supplier audits.
• Proven record of driving quality, compliance, operational performance, and continuous improvement initiatives.

Responsibilities

• Provide strategic leadership of manufacturing quality operations across all facilities and contract manufacturers.
• Develop and execute quality strategies that support business objectives, product quality, patient safety, and regulatory compliance.
• Establish quality goals, metrics, and performance indicators to drive continuous improvement and a culture of quality and accountability.
• Direct quality assurance activities supporting manufacturing processes and product release, ensuring robust oversight across inspection and disposition.

Skills

Quality leadership

Regulatory compliance

Lean Six Sigma

CAPA

Process validation

Risk management

Supplier quality

eQMS

FDA QSR

Education

Bachelor’s degree in engineering or related field

Tools

eQMS software

Job description

NIPRO Corporation - Global is seeking a Senior Director of Quality Manufacturing to oversee quality operations across eight manufacturing sites in North and South America. You will drive a world-class quality management system ensuring products, processes, and suppliers meet regulatory and customer expectations.

You will lead QA, Supplier Quality, Incoming Inspection, Production Quality, Validation, and Quality Engineering, shaping a culture of quality, compliance, and continuous improvement