Quality Systems & Risk Leader (On-Site)

Keller Executive Search; City of Rochester (NY); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Relocation assistance

Sign-on bonus

On-site role with limited remote work

Limited travel

Job summary

Keller Executive Search is partnering with a leading manufacturing organization to appoint an experienced Quality Systems and Risk Management Manager. This role focuses on developing and maintaining a robust quality management system, while advancing risk identification, mitigation, and control across the product lifecycle.

You will drive audit readiness, collaborate cross-functionally, and mentor the quality team to embed a culture of continuous improvement in a regulated manufacturing

Qualifications

• Bachelor’s degree in engineering, quality, life sciences, or a related technical field.
• 5+ years of experience in quality systems, quality assurance, or quality management within a manufacturing or regulated environment.
• Working knowledge of ISO 13485, FDA Quality System requirements, and ISO 14971 risk management principles.
• Practical knowledge of risk management methodologies and CAPA processes.
• Experience planning and conducting internal and external audits.
• Ability to work on-site as the primary work location.

Responsibilities

• Own, maintain, and continuously improve the quality management system to ensure ongoing compliance with applicable standards and regulations.
• Lead the organization’s risk management program, including risk assessments, mitigation planning, and CAPA.
• Plan, conduct, and coordinate internal and external audits, and manage responses to regulatory and customer audits.
• Develop, review, and control quality documentation, procedures, and records to support audit readiness.
• Manage supplier and contract-manufacturer quality, including qualification, monitoring, and periodic on-site assessments.
• Analyze quality data and trends to drive root-cause investigations and measurable improvements.
• Partner with operations, engineering, and supply chain to embed quality and risk controls across the product lifecycle.
• Lead, mentor, and develop quality staff and champion a culture of continuous improvement.
• Prepare and present quality and risk metrics and reports to senior management.

Skills

Regulatory compliance

Risk management

Audits

Data analysis

Documentation

Cross-functional collaboration

Education

Bachelor’s degree in engineering, quality, life sciences, or related technical field

Tools

QMS software

Job description

Keller Executive Search is partnering with a leading manufacturing organization to appoint an experienced Quality Systems and Risk Management Manager. This role focuses on developing and maintaining a robust quality management system, while advancing risk identification, mitigation, and control across the product lifecycle.

You will drive audit readiness, collaborate cross-functionally, and mentor the quality team to embed a culture of continuous improvement in a regulated manufacturing