Lead the organization’s Quality staff to ensure compliance to the overall Quality Management System and drive continuous improvement.
Lead the organization’s Quality staff to ensure alignment to manufacturing and servicing operations, support Lean efforts and drive quality improvement for products and services.
Work closely with Senior Management to provide strategic direction and development of the organization’s quality strategies and tactics.
Provide quality viewpoints and opinions on future product and service development.
Provide coaching, mentoring and leadership to the Quality staff.
Serve as the site’s Management Representative and lead the organization’s Management Review process.
Ensure compliance with appropriate domestic regulatory and international standards and requirements.
Lead the organization's continuous improvement process; including data analysis, improvement projects and process capability to improve key metrics as measured by the product/service quality dashboard.
Lead and develop effective production and process controls.
Manage the complaint handling processes to insure customer responsiveness and product and process improvements.
Ensure compliance to the New Product Development process and assurance that the Product Requirements Document includes key quality performance metrics.
Bachelor's Degree in Engineering or related technical field required.
An ASQC Certification is a plus.
10+ years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
8+ years of experience with medical device or other regulated industries preferred – Other regulated industries would be considered…Pharmaceutical, Aerospace, Automotive, Food & Beverage.
8+ years of experience working in an ISO certified environment required….ISO 13485 is ideal.
5+ years of experience in a Management or Leadership role.
ASQ, QSR or familiarity with QSR/GMP regulations preferred.