Quality Manager

Position Summary

The Quality Manager is responsible for leading quality improvement for a manufacturing or service facility/function. This position leads the implementation and maintenance of state-of-the-art quality practices for associated product and service lines. The Quality Manager assumes overall responsibility in ensuring that the site maintains operational and quality systems in a state of compliance to domestic and international standards.

Functional Knowledge, Skills & Abilities

• 8-10 years' experience in Manufacturing/Quality Engineering and/or Quality Systems
• 8-10 years' experience working in an ISO certified environment required
• 8-10 years' experience working In a Quality leadership role
• Bachelor's degree required
• Experience with ASQ, QSR or familiarity with QSR/GMP regulations
• Medical device or other regulated industries preferred
• Excellent problem-solving skills
• Focus on identification of potential issues and continuous improvement
• Experience working on cross-functional teams and on own initiative
• Demonstrated excellent organizational, oral and written communications skills
• Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint
• Experience with statistical analysis software and Visio preferred

Lead the organization’s Quality staff

• Ensure compliance to the overall Quality Management System
• Drive continuous improvement
• Lead the organization’s Quality staff to ensure alignment to manufacturing and servicing operations
• Support Lean efforts

Provide quality viewpoints and opinions

• On future product and service development

Coaching, mentoring and leadership

• To the Quality staff

Site’s Management Representative

• Lead the organization’s Management Review process

Compliance with standards

• Ensure compliance with appropriate domestic regulatory and international standards and requirements

Continuous improvement process

• Lead and implement effective production and process controls
• Manage the complaint handling processes to ensure customer responsiveness and product and process improvements
• Ensure compliance with the New Product Development process and assurance that the Product Requirements Document includes key quality performance metrics
• Determine supplier qualification risks based upon criticality of component and supplier process capability
• Determine supplier qualification risks based upon criticality of component and supplier process capability

Other duties as assigned