Senior Director, Quality Assurance for Global P&R

Enovis•Dallas, TX

About The Position

At Enovis™ we pay attention to the details. We embrace collaboration with our partners and patients and take pride in the pursuit of scientific excellence — with the goal of transforming medical technology as we know it. Because that’s how we change the lives of patients for the better. And that’s how we create better together. As a key member of the Enovis Global Quality team you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes. The Senior Director, Quality Assurance for Global P&R Group will be responsible for the Quality Management System and Processes in the Global P&R Group. They will be expected to bring leadership and support to the product launch process in a timely predictable manner by using their own significant body of experience. They will be responsible for Quality compliance through the entire life cycle of medical device products, including all aspects of Operations, Supply Chain, Logistics, and post market surveillance (complaints). As such, they will be expected to be a strong leader of site and business unit level Quality Assurance personnel. Strong oversight of key performance indicators and metrics scorecards from a remote location will be key to driving the success of the department. The successful candidate will be a competent and proven leader in the QA field, fully understanding to a high-level the regulations and quality system needs involved in bringing innovative products to market and maintaining them. They will develop and maintain expert knowledge in changing and developing business needs and develop their team as a key focus.

Requirements

Bachelor's degree in analytic field or equivalent.
10+ years’ relevant experience in regulated industries - Medical Device.
7-10+ years’ experience leading leaders.
Applicants must already have full-time work authorization in the United States, both now and in the future, without requiring sponsorship.

Nice To Haves

Experience in both R&D and Operations Quality preferred.
MBA a plus or other advanced degree.

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.