Quality Systems Specialist - Manufacturing - Shirley, MA

This role leads and governs a site-wide Quality Management System, ensuring full compliance with ISO standards and regulatory expectations. You'll own internal audits, drive continuous improvement, and serve as the on-site expert for quality systems and audit readiness.

• Lead ISO audits & shape QMS strategy at a global manufacturer
• High-impact role with growth, autonomy, and cross-site influence, * Ensure the site QMS remains compliant with ISO standards, regulatory requirements, and corporate policies
• Manage QMS documentation, maintaining structure, accuracy, and version control
• Partner with cross-functional teams to align procedures with real-world operations and compliance needs
• Develop and maintain quality manuals, process maps, and system frameworks
• Own and execute the internal audit program, ensuring full annual coverage
• Plan and perform system, process, and regulatory audits across departments
• Evaluate audit evidence, identify nonconformities, and deliver detailed reports
• Drive corrective action processes through to effective resolution
• Train and mentor internal auditors as the program evolves
• Conduct gap analyses and lead certification readiness efforts
• Oversee key QMS elements (CAPA, training, supplier quality, risk, validation, etc.)
• Support management reviews through performance metrics and compliance reporting
• Partner with Quality Control to investigate system-level issues and root causes
• Lead continuous improvement initiatives driven by audit findings and risk assessments
• Deliver training on QMS processes, documentation practices, and audit readiness
• Act as the site expert on ISO interpretation and quality system best practices
• Supervise document control and training coordination resources

• Experience within quality systems in a manufacturing environment
• Strong background in ISO-compliant QMS implementation, maintenance, or auditing
• Bachelor's degree in Engineering, Life Sciences, Quality, or related field
• Formal internal or lead auditor certification/training
• Deep knowledge of QMS elements (CAPA, document control, risk, supplier quality, etc.)
• Excellent written and technical documentation skills
• Ability to interpret regulations and translate into practical procedures
• Strong analytical, organizational, and problem-solving capabilities
• Proven ability to influence and challenge stakeholders constructively
• Ability to work independently while leading cross-functional initiatives

• Visible, high-impact role with ownership of site-wide quality systems
• Strong career growth within a global, well-backed organization
• Collaborative culture with cross-functional exposure
• Competitive salary plus robust benefits (401k, parental leave, PTO)
• Opportunity to lead audits and shape compliance strategy

Our client is a global, publicly traded industrial engineering organization with a strong reputation for innovation and sustainability. They operate across multiple critical industries and are known for investing in employee growth, inclusion, and long-term career development.