Senior Director, Quality Manufacturing

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

The Senior Director, Quality Manufacturing is a strategic leadership role responsible for overseeing quality operations across eight manufacturing sites throughout North and South America. This executive leader will drive the development, implementation, and continuous enhancement of a world-class quality management system that ensures products, processes, and suppliers consistently meet regulatory requirements, industry standards, and customer expectations.

Reporting as a key member of the leadership team, this role provides direction and oversight for Quality Assurance, Supplier Quality, Incoming Inspection, Production Quality, Validation, and Quality Engineering functions supporting commercial manufacturing operations.

The Senior Director will champion a culture of quality, compliance, accountability, and continuous improvement while fostering operational excellence across the organization. This individual serves as a trusted partner to Operations, Regulatory Affairs, R&D, Supply Chain, and Executive Leadership, influencing business strategy and driving quality initiatives that support organizational growth and performance. The successful candidate will ensure compliance with global regulatory and quality standards, including FDA regulations, ISO 13485, EU MDR, MDSAP, and other applicable requirements, while leading teams through a dynamic and evolving regulatory environment.

This is an exceptional opportunity for a visionary quality leader who is passionate about developing high-performing teams, advancing manufacturing excellence, and delivering best-in-class quality outcomes in a highly regulated industry.

Essential Duties and Responsibilities:

• Provide strategic leadership and oversight of manufacturing quality operations across all manufacturing 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. Promote a culture of quality, compliance, accountability, and operational excellence.
• Direct quality assurance activities supporting manufacturing processes and product release. Ensure robust quality oversight of incoming inspection, in-process controls, final product acceptance, and product disposition.
• Lead investigation and resolution of quality issues, nonconformances, product failures, and manufacturing deviations. Oversee quality engineering activities related to process validation, equipment qualification, and manufacturing controls.
• Ensure compliance with FDA Quality System Regulation (QSR), ISO 13485, MDSAP, EU MDR, and applicable international quality requirements.
• Maintain a state of continuous audit and inspection readiness.
• Lead organizational preparation and response for regulatory inspections, notified body audits, customer audits, and supplier audits.
• Partner with Regulatory Affairs to assess and implement regulatory changes impacting manufacturing quality systems.
• Provide oversight of supplier qualification, performance monitoring, auditing, and corrective action activities.
• Establish effective supplier quality management programs to ensure supplier compliance and product quality.
• Drive process improvements through Lean Manufacturing, Six Sigma, risk management, and operational excellence methodologies.

Managerial Responsibilities:

• Build, lead, and mentor high-performing manufacturing quality teams.
• Develop succession plans and talent strategies to support organizational growth.
• Foster employee engagement, professional development, and leadership capabilities.
• Create an environment that encourages collaboration, innovation, and accountability.

Education, Certifications and/or Work Experience Requirements:

• Bachelor’s degree in engineering, Life Sciences, Quality Assurance, Manufacturing, Industrial Engineering, or related technical field
• 15+ years of progressive quality leadership experience within the medical device, biotechnology, pharmaceutical, or highly regulated manufacturing industry.
• 8+ years of leadership experience managing manufacturing quality and compliance programs.
• Demonstrated success leading quality organizations within FDA-regulated manufacturing 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.

Preferred:

• Experience in global medical device manufacturing organizations.
• Experience managing quality systems across multiple manufacturing sites.
• Experience supporting mergers, acquisitions, product transfers, or manufacturing scale-up initiatives.

Skills/Knowledge Requirements:

• Expert knowledge of FDA Quality System Regulations (21 CFR Part 820), ISO 13485, ISO 14971, MDSAP, EU MDR,
• and other global medical device regulatory requirements.
• Comprehensive understanding of medical device manufacturing quality systems and regulatory compliance.
• Strong experience with CAPA, nonconformance management, complaint handling, supplier quality, validation, risk
• management, and change control processes.
• Knowledge of design controls and product lifecycle quality requirements.
• Deep understanding of manufacturing processes, process controls, equipment qualification, and process
• validation.
• Experience implementing Lean Manufacturing, Six Sigma, and continuous improvement methodologies.
• Strong knowledge of statistical process control (SPC), root cause analysis, and quality risk management tools.
• Experience with electronic Quality Management Systems (eQMS) and enterprise business systems.

Physical Requirements:

• Ability to work in office and manufacturing environments.
• Ability to stand, walk, sit, and use computer equipment for extended periods.
• Ability to access manufacturing and warehouse areas while following applicable safety requirements.
• Ability and willingness to travel to company manufacturing and operational facilities up to 30-40% of the time.