Job Description

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1st Shift

$150-$175k/yr

Job Description/Duties/Responsibilities:

Why is the Global Director of Quality important to us?

We are seeking a Global Director of Quality to oversee quality standards across our global facilities in Italy, France, the UK, Seattle, and Michigan. This leader will align our quality management systems with internal, customer, and regulatory requirements in numerous regions, reinforcing our commitment to excellence in on-demand manufacturing.

The Global Director of Quality will be responsible for developing, implementing, and maintaining theorganization’s Quality Management Systems (QMS), ensuring ISO9001 compliance and initiating ISO13485 processes where necessary. They will collaborate across teams, promote a culture of continuous improvement, and provide strategic guidance to uphold operational excellence.

In this role, you will:

*Implement and maintain a global Quality Management System aligned with ISO9001 standards, incorporating ISO13485 requirements when needed.

*Develop key performance indicators and drive continuous improvement initiatives across all global facilities.

*Ensure compliance with customer, internal, and regulatory/legal requirements, maintaining strict quality control measures.

*Strategically evaluate production operations to confirm product integrity, functionality, and compliance with global standards.

*Collaborate with senior management, production teams, and cross-functional stakeholders to establish and uphold quality benchmarks.

*Lead a dedicated team of quality inspectors and technicians, promoting a hands-on approach to floor-based coaching and engagement.

*Oversee process integration flow mapping, inspection of incoming materials, and calibration of monitoring devices.

*Conduct periodic management reviews, reporting quality metrics and improvement opportunities to executive leadership.

Minimum Skills/Mandatory Skills/Experience Needed for Hire:

*15+ years of experience in Quality Assurance/Quality Control within a manufacturing environment.

*A bachelor’s degree in engineering or quality (preferred).

*Proven expertise in implementing and maintaining ISO9001 QMS; ISO13485 background highly desired.

*Familiarity with Lean & Six Sigma methodologies, 3D software, project management, and strong proficiency with Microsoft Office.

*Excellent communication skills, strong organizational abilities, and the capacity to maintain strict confidentiality.

*Ability to work in both office and production floor environments, including readiness to engage in hands-on physical tasks when needed.

Safety Supplies Required/Provided/Entering & Parking/Dress Code/Additional Information/etc.:

Background/Screening/Licensing Requirements:

Drug Screen: Yes

Marijuana Permitted: No

Background Check: Yes

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