Qual Systems Manager

The Quality Systems Manager is responsible for leading the development, implementation, and continuous improvement of the Quality Management System (QMS) of Micro. This role ensures compliance with applicable regulatory requirements, industry standards, customer requirements, and internal policies while driving operational excellence across quality processes. The position partners closely with cross‑functional leaders to promote a culture of quality, compliance, and continuous improvement.

• An effective and audit‑ready Quality Management System is maintained that consistently supports compliance with customer requirements, regulatory requirements, certification standards, and business objectives.
• Customer, regulatory, certification, and third‑party audits and inspections are successfully completed with minimal findings, sustained approvals, and continued organizational confidence in the effectiveness of the Quality Management System.
• Corrective and preventive actions are implemented, verified for effectiveness, and completed in a manner that eliminates root causes and prevents the recurrence of quality system issues.
• Complaints, deviations, nonconformances, and related quality system events are investigated, resolved, and closed within established time frames while maintaining compliance and minimizing organizational risk.
• Quality system improvements strengthen compliance, reduce risk, improve operational effectiveness, and enhance the organization's ability to consistently meet customer and regulatory expectations.

• Lead and continuously improve the Quality Management System to sustain compliance with applicable regulatory, customer, and business requirements.
• Govern quality system processes to keep them effective, sustainable, and aligned with ISO, FDA, GMP, and applicable standards — preventing lapses that jeopardize certifications or approvals.
• Serve as the subject‑matter expert on quality systems and regulatory compliance, giving leaders and teams trusted guidance that drives confident, compliant decisions.
• Facilitate Management Review with meaningful performance data that equips leadership to make informed decisions and prioritize improvements.

• Execute an effective internal audit program that surfaces risks early, drives corrective action, and delivers measurable continuous improvement.
• Host and manage external audits and regulatory inspections so they run smoothly and sustain the company’s certifications, registrations, and customer approvals.
• Drive resolution of audit findings within established timelines and verify their effectiveness, eliminating overdue and recurring issues.
• Serve as the primary contact for regulatory bodies and third‑party auditors, building transparent and constructive relationships.
• Manage complaint handling, investigation, nonconformance, and CAPA processes to consistently meet regulatory and customer requirements.
• Lead continuous improvement initiatives that measurably reduce quality risk, strengthen compliance, and improve process efficiency.
• Analyze quality system data and trends to target and act on systemic improvements before issues occur.

• Maintain document control processes that keep quality system documentation accurate, accessible, revision‑controlled, and compliant at all times.
• Keep all SOPs, policies, and procedures current and aligned with actual practice, eliminating outdated or uncontrolled documents.
• Deliver quality system training programs that build employee competency and meet compliance requirements.
• Monitor training completion and effectiveness to keep the organization audit‑ready and operationally capable.

• Directly supervise multiple employees in the Quality department and carry out supervisory responsibilities in accordance with the organization’s policies and applicable laws.
• Lead, mentor, and develop quality systems staff.
• Drive accountability to deliver on Quality Goals.
• Foster a strong quality culture across the organization.

• Bachelor’s degree in Engineering, Quality, or a related field is…