Quality Systems and Risk Management Manager

About the role

Reporting into senior leadership, you will own the design, maintenance, and continuous improvement of the quality management system while leading a structured approach to risk identification, mitigation, and control across the product lifecycle. You will work cross‑functionally with operations, engineering, supply chain, and external partners to ensure that quality standards, regulatory requirements, and customer expectations are consistently met. This is an excellent opportunity to shape quality strategy, strengthen audit readiness, and embed a culture of continuous improvement. The client values rigor, collaboration, and forward‑thinking problem solving, offering a stable, growth‑oriented environment where quality leadership is genuinely valued.

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 corrective and preventive actions (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

Requirements

• 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
• Strong analytical, documentation, and problem‑solving skills
• Ability to work on‑site as the primary work location

Qualifications

• Professional certification such as CQE, CQM, CQA, Six Sigma, or Lead Auditor
• Experience with regulated or highly controlled manufacturing environments
• Prior people‑management or team leadership experience
• Experience managing supplier or contract‑manufacturer quality
• Experience with electronic quality management systems

Skills

• Detail‑driven yet strategically minded, balancing compliance discipline with practical continuous‑improvement thinking
• Clear communicator across functions, able to influence without authority and stay calm and organized during audits
• Takes ownership of quality outcomes and enjoys building robust systems that scale

Benefits

• Relocation support is available for candidates who are not local; this can be structured as coverage of relocation costs or as a flat sign‑on bonus to help the successful candidate make the move

Schedule

Primarily on‑site with occasional remote flexibility based on business needs.