Senior Director, Global Quality Management Systems

Role Overview

• Manage Regional and site-level Quality System compliance, ensuring full compliance of the site Quality System with US FDA, ISO 13485, and other applicable regional and/or country-specific regulatory requirements.
• Ensure day to day manufacturing operations is completed in alignment with Operational targets and objectives.
• Facilitate and support regional expansion plans for both new product launches and manufacturing foot print.
• Establish, maintain and promote a strategy for compliance with quality objectives.
• Ensure timely and accurate evaluations and investigations.
• Implement prompt actions as necessary to ensure product safety and efficacy based upon investigation results.
• Manage and ensure follow-up on activities related to Internal and External QMS Audits.
• Establish, maintain and promote a culture of compliance and a keen focus on quality and customer requirements throughout the site organization.

Requirements

• Bachelor's degree (preferably science or engineering discipline) required.
• At least 15 or more years of experience in Medical Device Quality Operations with 10 or more years at the Quality Manager level.
• Broad extensive knowledge of methods, processes, equipment, and techniques in manufacturing, development and engineering.
• Significant knowledge and experience with designing and implementing QMS processes that meet the requirements of ISO 13485, 21 CFR 820, and MDR.
• Intermediate to advanced skill level of MS Word, Excel, Access, Auto Cad or equivalent.

Benefits

• Medical, dental, and vision insurance
• 401(k) with company match
• Paid time off (PTO)
• And additional employee wellness programs