02 Nov
Compliance Development Quality Engineer
Texas, Plano , 75023 Plano USA

Description Details They are seeking an experienced, high caliber Development Quality Engineer to assure new or modified products conform to product / quality standards and establish compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. We are team-oriented, fast-paced, and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.

Responsibilities: Participate in or lead teams in supporting quality disciplines, decisions, and practices for programs to develop the next generation of devices (e.g., represent the Quality function as a Project Team Member on development programs). Support on-time execution of Design Development Plans and Design Change Plans for internal product development process (PDP) Work with design engineering to execute and/or support various areas of Design Control QS processes, such as Design Input requirements, Design outputs, Design verification and Design validation Ensure compliance to product standards (60601-x; 14708-x) Generate protocols and execute safety testing at external test labs Generate essential requirements checklists & reports Lead identification of essential outputs and generate Essential Output reports Complete Document Change Order Reviews in a timely and objective manner Lead Risk Management activities from product Concept through Commercialization. Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps (e.g. Design review robustness) Other Duties: Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues Exercise judgment in planning and organizing work; monitor performance and report status Bring additional development expertise to the product development process Build strong collaborative partnerships with Program Management and Research & Development to ensure cross functional needs are met without creating barriers to development cost, time, and scope. Your experience(s), education and knowledge will further expand organization's marketplace success: Bachelor level degree in Electrical Engineering or Technical Field 5-8 years' experience Previous Medical Device safety testing experience Prior design and development experience in a related field Working knowledge of FDA 21 CFR Part 820, GMP, ISO13485, ISO 14971, EN 45502-1, ISO14708, AIMDD etc. Excellent verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization Strong analytical/problem solving, negotiation, and presentation skills. Project management and leadership skills, including the demonstrated ability resolve quality-related issues with cross-functional teams in a timely and effective manner Advanced computer skills, including statistical/data analysis and report writing skills Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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