Senior Manager, QMS

Responsibilities

• Own and continuously improve the enterprise Quality Management System (QMS) across manufacturing and operational facilities.
• Establish QMS policies, standards, governance mechanisms, and risk-based quality controls.
• Maintain compliance with ISO 9001, customer standards, and applicable regulations.
• Lead internal, customer, supplier, certification, and regulatory audits, including planning, execution, and finding closure.
• Govern nonconformance (NCR) and Corrective and Preventive Action (CAPA) processes, including root-cause analysis, containment, and effectiveness verification.
• Manage quality document control, records governance, and engineering/operational change control.
• Partner with IT and business systems teams to integrate QMS data with ERP, MES, and inspection tools.
• Establish cross-site quality dashboards and lead Quality Management Reviews with executive leadership.
• Define QMS training requirements, maintain competency records, and promote quality awareness.
• Lead Lean Six Sigma and continuous-improvement initiatives.
• Maintain quality risk registers and ensure appropriate oversight of high-risk processes.
• Lead QMS readiness for greenfield manufacturing sites before production launch.
• Drive systemic issue resolution across Product Quality, Supplier Quality, Manufacturing Quality, Engineering, Operations, Supply Chain, and EHS.

Requirements

• Bachelor's degree in Quality, Engineering, Manufacturing, Industrial Engineering, Operations, or a related field.
• 7+ years of experience in Quality, QMS, Quality Engineering, or Manufacturing Quality.
• Experience developing and scaling QMS frameworks.
• Deep knowledge of ISO 9001, quality management principles, and regulatory compliance.
• Experience managing internal, customer, regulatory, and third-party certification audits.
• Expertise in CAPA, NCR, 8D, 5-Why, Fishbone, and structured problem-solving methods.
• Experience with quality document control, record retention, and change management.
• Ability to lead cross-functional initiatives and influence stakeholders without relying solely on direct authority.
• Excellent written, verbal, analytical, and executive communication skills.

Nice-to-haves

• ASQ Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or Certified Manager of Quality/Organizational Excellence (CMQ/OE).
• Lean Six Sigma Green Belt or Black Belt certification.
• Experience leading ISO 9001 implementation, recertification, or multi-site expansion.
• Experience implementing QMS platforms such as MasterControl, ETQ, or Veeva.
• Experience integrating QMS with ERP and MES systems.
• Experience scaling QMS frameworks in fast-growing manufacturing organizations or launching greenfield facilities.
• Experience using AI, predictive analytics, or digital transformation tools in quality management.

Compensation and Benefits

• $135,000–$155,000 annual compensation, plus bonus.
• Restricted Stock Units included in all offers.
• Paid time off, paid holidays, and leave programs.
• Health, dental, and vision insurance.
• Employer HSA contributions.
• Paid parental leave, life insurance, and short- and long-term disability.
• Professional development and tuition reimbursement.
• Mental health and wellness support.
• Commuter benefits and cell phone stipend.
• 401(k) with company match up to 4% of salary.
• Volunteer time off, global travel insurance, emergency assistance, daily meals allowance, and location-specific programs.