Enovis · 1 day ago
Senior Director, Quality Assurance for Global P&R
Dallas, TX
Full-time
Onsite
Director/Executive
10+ years expEnovis Corporation is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions for better patient outcomes. The Senior Director, Quality Assurance for Global P&R will lead the Quality Management System and ensure compliance throughout the product life cycle, collaborating with various departments to support product launches and regulatory pathways.
Health CareManufacturingMedicalMedical DeviceProduct Design
No H1B
Responsibilities
Provide general direction, tactical objectives, and functional plans for execution of Quality Assurance Department
Develop strategy and key initiatives for Enovis’s Quality Management System in relation to all aspects of a commercial and operating company, including the entire product life cycle
Develop, communicate, and track goals and objectives necessary to the success of the Quality Assurance Department, as it relates to the success of the Company
Partner with Sales, Customer Service, R&D, Operations, and Logistics to ensure appropriate compliance and activities for a regulated Medical Device organization
Develop product launch processes in the US, Europe, Japan, Australia, and other global regions to meet the needs of the Enovis’s business and its overall strategic plans
Support through solid integration planning and execution product and business acquisitions in relation to Quality requirements
Develop and maintain product and system quality requirements for product transfers
Experience and knowledge in FDA Class I, II, and III devices, specifically to current 510(k) and PMA application processes and the associated activities (PMA submissions, PMA annual reports, 510(k) updates)
Experience and knowledge of global product pathways
Partner closely with Regulatory Affairs to ensure proper clinical strategies and execution to support the Regulatory product pathways for both approvals and maintenance
Responsible for monitoring product complaints and assessing product safety and efficacy in the marketplace
Responsible for ENOVIS Quality Assurance Special Processes not otherwise listed
Ensure that all policies and strategies at ENOVIS are in full compliance with all applicable Global regulatory requirements in their chosen markets while still maintaining operational efficiency for the company
Regularly consult with business leaders to develop corrective action plans and strategies to improve the business processes and results
Effectively manage change to ensure compliance with business needs and industry regulations in the changing global regulatory landscape
Work is accomplished through managers, principles, specialists, and associates
Provide guidance to subordinates to achieve goals and develop expertise
Exercise the usual authority of a manager including selection and development of staff, talent acquisition and performance management
Qualification
Required
Bachelor's degree in analytic field or equivalent
10+ years' relevant experience in regulated industries - Medical Device
7-10+ years' experience leading leaders
Experience in both R&D and Operations Quality preferred
MBA a plus or other advanced degree
Benefits
Medical Insurance
Dental Insurance
Vision Insurance
Spending and Savings Accounts
401(k) Plan
Vacation, Sick Leave, and Holidays
Income Protection Plans
Discounted Insurance Rates
Legal Services
Company
Enovis
Enovis is a medical technology company that develops orthopedic medical devices.
5001-10000 employees
Funding
Current Stage
Public CompanyTotal Funding
$400M2023-10-20Post Ipo Debt· $400M
2022-04-05IPO
Leadership Team
Damien McDonald
CEO
Mitchell P. Rales
Co-Founder
Recent News
GlobeNewswire
2026-01-23
2026-01-22
2026-01-13
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