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.

JOB OUTCOMES

The Quality Systems Manager is expected to:

·         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 timeframes 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.

ESSENTIAL DUTIES and RESPONSIBILITIES

Quality Systems Leadership

• 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.

Compliance & Auditing

• 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.

Complaints, CAPA & Continuous Improvement

• Manage complaint handling, investigation, nonconformance, and CAPA processes to consistently meet regulatory and customer requirements.


• Drive problems to root cause and implement verified corrective actions so that issues do not recur.


• 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. 

Document Control & Training

• 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.

TALENT MANAGEMENT

Directly supervises multiple employees in the Quality department. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

• Lead, mentor, and develop quality systems staff


• Drive accountability to deliver on Quality Goals


• Foster a strong quality culture across the organization

EDUCATION AND EXPERIENCE

·         Bachelor’s degree in Engineering, Quality or a related field is required

·         8-10 years of quality experience in a manufacturing environment or equivalent combination of education and experience is required

·         Strong experience managing Quality Management Systems in a regulated industry (e.g., medical device, manufacturing)

·         Experience in developing one or more Quality Systems (e.g., CAPA, Internal Audit program, Complaints)

·         Experience leading audits is required

·         Experience hosting audits is required

·         Experience with electronic QMS systems preferred

LICENSE AND CERTIFICATION

Preferred Certifications

• ASQ Certified Quality Manager (CQM) / Certified Quality Engineer (CQE)


• Lead Auditor certification (ISO standards)

·         Six Sigma (Green Belt/Black Belt) preferred

OTHER SKILLS

·         Ability to work on multiple projects

·         Excellent leadership and team management ability

·         Strong ability to present data/information to various levels of management and at the appropriate level of detail

·         Strong ability to assess risk/impact so that projects/initiatives can be appropriately prioritized

·         Must have exceptional organizational skills, ability to meet deadlines, thrive in a fast-paced environment and be able to solve problems effectively

·         Proficient with MS Office Suite.  Advanced skills in Excel for data analysis is preferred