Job Description – Vice President, Global Quality Assurance
Specific points of interest:
- The position will be based in Lewisville, TX (Dallas area)
- Relocation will not be required during the COVID pandemic operating time frame (the target timeframe for relocation is the end of 2021)
- Leads a global team of 9 site leaders
- Develop a talented team of leaders to deliver support and solutions to their local teams and locations
- Institute and manage metrics and scorecards for all locations, including a corporate level roll up and executive communication
- Evaluate current processes and improve quality, throughput, efficiency of product registration successes
- Develop a strong quality system, with both global processes and procedures along with localized solutions when necessary
- Responsible for all QA / QC aspects of a global medical device company covering class I / II / III (US) products
- Department’s primary goal is ensuring safety, efficacy, and compliance of products and services to our customers. This is delivered through a strong and functional Quality Management System for all sites.
- Primary point of contact for all local support on Quality Systems, quality assurance, quality engineering
- Coordinate with Regulatory and Clinical leadership to establish appropriate product launch strategies for new product approvals, expansion opportunities
- Direct support to Operations and R&D areas for necessary Quality Assurance support, including (but not limited to) risk management, product resolution, incoming inspection, and internal audits
- $1.2B business, growing in low single digits each year
- Strategy includes significant expansion and acquisition, integration of acquired businesses is expected
- Needs extensive experience with leading dedicated individuals to deliver support and solutions in all classes of medical devices (US Class I / II / III, EU Class I / IIa/ IIb / III)
- Strong leadership skills, but player / coach
- Will need to dive in and get work done, while also leading the RA team and developing strategy and managing existing talent and identifying needs for a growing business unit
The VP Quality Assurance for DJO will be responsible for all aspects of Global Quality Management System across all therapeutic and treatment platforms. They will be expected to bring leadership and support to the product lunch process in a timely predictable manner by using their own significant body of experience particularly in the USA and the EU/ UK markets. 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.
Essential Duties and Responsibilities:
- Provide general direction, tactical objectives, and functional plans for execution of Quality Assurance Department
- Develop strategy and key initiatives for DJO’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 DJO’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
- Primary point of contact for all Quality Assurance needs within the local operations / business unit
- 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 including EU CE (MDD and MDR), Japanese MHLW, Australian TGA, and others
- 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 DJO Quality Assurance Special Processes not otherwise listed.
- Ensures that all policies and strategies at DJO are in full compliance with all applicable Global regulatory requirements in our 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
- Provides guidance to subordinates to achieve goals and develop expertise
- Exercises the usual authority of a manager including selection and development of staff, talent acquisition and performance management
- Collaborate, influence and build strong sustainable business relationships with various functions and levels throughout the organization.
- Clearly and concisely communicate orally and in writing to individuals and groups in a compelling manner.
- Interpret and understand regulatory requirements on a global scale, and implement proper process and system changes to meet changes in regulations
- Make decisions using insights, data, and cross functional collaboration inputs.
- Adapt and support the organization through times of change
- Precisely and proficiently conduct business and data analyses and forecasts with data driven recommendations for improvements and advancements.
- Operate and use telephones, computers/laptops and other technological devices/software programs to communicate with other people.
To perform this job successfully, an individual must be able to perform essential duties satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
- Bachelor's degree in analytic field or equivalent.
- 15+ years relevant Quality experience - Medical Device
- Experience in both R&D and Operations Quality preferred
- Previous people management experience, including supervision of leaders
- Proficient in Microsoft Office Suite (Outlook, Excel, Word, and Power Point)
- Oracle experience as an ERP preferred (Inventory, MRP, ASCP)