Staff QMS Specialist

JOB SUMMARY

The Staff QMS Specialist will be a strategic leader and trusted advisor responsible for advancing, integrating, and optimizing the company's Quality Management System (QMS) across all facilities worldwide. This role partners with business and functional leaders to align QMS with enterprise objectives, leads (complex) internal audits, drives cross-site harmonization, to help shape the company's quality culture. Operating with high autonomy, the Staff QMS Specialist mentors peers, influences executive decisions, and champions continuous improvement and compliance. The incumbent will serve as the Management Representative for assigned sites as needed.

JOB DUTIES AND RESPONSIBILITIES

QMS Leadership

· Develop and execute long-term QMS strategies aligned with corporate goals and customer/regulatory expectations.

· Partner with Operations, Engineering, Supply Chain, and HR leaders to embed QMS practices into daily management systems; mentors Process Owners.

· Lead cross-site harmonization of QMS processes, documentation, and governance.

Internal Auditing

· Design and run a comprehensive internal audit program covering process and system audits.

· Conduct audits domestically and internationally; analyze systemic issues and drive organization-wide corrective actions.

· Ensures organizational readiness for ISO 9001, and other regulatory audits.

· Establishes internal auditor training and qualification programs.

QMS Optimization & Integration

· Champion QMS metrics, defining KPIs and analytics for executive visibility.

· Integrate new/updated standards into the QMS and ensure effective deployment.

· Supports deployment, integration, and governance of electronic QMS platforms, digital workflows, and document control systems.

Change Management & Culture Building

· Serve as a change agent; influence cross-functional and cross-cultural teams to adopt QMS principles.

· Design and deliver advanced training for leaders and staff; establish best practices for Process Owners.

· Create recognition mechanisms to reinforce QMS ownership and adherence.

Global/External Engagement

· Leads in certification body audits and major customer/industry audits.

· Benchmark against industry best practices and regulatory trends; translate insights into action.

Documentation, Governance & Reporting

· Oversee development and maintenance of policies, procedures, and work instructions.

· Prepare reports, roadmaps, and recommendations for Management Review activities and decision-making.

JOB REQUIREMENTS AND MINIMUM QUALIFICATIONS

Qualifications

· Bachelor’s degree in Engineering, Science, Business, or related field (Master’s preferred).

· Minimum 10 years’ experience in quality systems management, internal auditing, or QMS leadership.

· Experience implementing and maintaining ISO 9001 within complex, multi‑site environments.

· ISO 9001 Lead Auditor certification required; ASQ (CQA/CQE), Six Sigma (Black Belt), or equivalent advanced certifications preferred.

· Demonstrated success leading QMS transformation, integration, and optimization projects.

· Expert knowledge of document control, process mapping, risk management, and CAPA systems.

· Proven ability to influence leaders, lead cross-functional and cross-cultural teams, and drive cultural change.

· Exceptional analytical, communication, facilitation, and training skills.

· Ability to operate independently, prioritize strategically, and deliver results in a fast-paced environment.

· Willingness and ability to travel globally up to 30% of the time (or as business needs require).

Pay: $150,000.00 - $175,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Tuition reimbursement
• Vision insurance

Work Location: In person

Salary : $150,000 - $175,000