Mentor Worldwide L.L.C., a member of the Johnson & Johnson family of companies, is recruiting for a Director of Quality Assuance for its location in Irving, TX.
Mentor Worldwide L.L.C is a trusted global leader in aesthetic medicine among both consumers and clinicians by providing a broad range of innovative, science and clinical-based solutions to maintain, enhance, and restore self-esteem and quality of life. The company has products and services in three areas of aesthetics: breast (augmentation and reconstruction), body and face.
Directly supervises the leaders of the Quality Operations, Microbiology, and Document Control departments.
Â· As a part of the site management team, provides business leadership and technical quality expertise to the Operation.
Â· As part of the site management team, develops the appropriate plans to support and meet the Corporate, Franchise, Region and Site operating Goals and Objectives.
Â· Ensures compliance with FDAâs Quality System Regulations, ISO 13485:2003 Medical Device Directive, Canadian Medical Device Regulations, and other applicable industry standards.
Â· Performs the duties of Management Representative for the quality systems at Mentor Texas, as defined in the appropriate Quality Manuals.
Â· Acts as liaison with the quality system registrar, FDA and BSI Notified Body.
Â· Implements and directs the use of Quality Engineering principles, tools and techniques to develop and optimize systems and processes that are aligned with the overall Company strategy and mission, driving continuous quality improvement.
Â· Leads the Quality Assurance staff, works with team members to generate career development plans, and provides coaching to address technical and leadership challenges.
Â· Coordinates and leads the siteâs quality assurance strategy and its execution to ensure the production of quality products consistent with specifications, established standards, and in compliance with regulatory and industry standards.
Â· Develops and manages the Quality Operations strategy, leading the alignment across Mentor sites
Â· Provides guidance to the Quality Engineering function in regards to reliability engineering, design control, product and process improvement efforts and product specification development.
Â· Builds cross-functional support through influence and persuasion in order to facilitate continuous product and process improvement.
Â· Partners across sites to learn about, develop, and implement best practices
Â· Leads continuous quality improvements throughout the entire life cycle of Mentor products, including providing input into new product design and development, optimizing manufacturing for commercialized products, providing input into continuous improvement plans for sourced components, and leading customer-driven quality improvement teams.
Â· Is technically competent to evaluate design control/product validation activities and data to ensure that design control/validation activities and data are appropriately implemented and utilized to support desired objections and conclusions.
Â· Develops performance objectives for the Quality function based upon corporate and plant quality objectives. Has both the authority and responsibility to assure these goals are attained. Prioritizes goals for the QA/QE function to achieve deadlines.
Â· Responsible for developing, managing and executing the Quality budget including Cost Improvement and Capital Investment projects.
Â· Monitors the key quality performance measures and the corrective action results. Responsible for the CAPA and Non-Conforming Product systems and reporting on the results to management with executive responsibility; recommending and initiating appropriate corrective action as appropriate.
Â· Oversees the internal audit program that complies with regulations, Mentor policies and measures the effectiveness of the quality system.
Â· Serves as the site management representative as defined in the quality System Regulation and ISO 13485:2003.
Â· Directly responsible for hosting all external audit such as Medical Device Single Audit Program and OCP.
Â· Oversees the development of all new product and line extension launches
Â· Manages QA personnel and resource allocation to meet QA objectives at the Mentor TX site.
Â· Bachelor's degree in an applied technical discipline.
Â· Based on education and or experience be able to provide appropriate technical input and review of design control and validation activities.
Â· Minimum of ten years of experience in a regulated field, supporting Manufacturing, Quality, and/or Compliance.
Â· Experience in other J&J franchises or external businesses operating in a regulated field is preferable.
Â· Prior management experience required.
Â· Medical device manufacturing experience required.
This position is located in Irving, TX and may require some travel.
Mentor Texas LP (6182)
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• Post ID: 51612818 northdfw