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In this exciting role as a Sr. Software Quality Engineer, you will serve as a subject matter expert by leading and providing technical design quality support for the new product development and sustaining projects. The individual will act as a subject matter expert and provide guidance to the business in interpreting and executing against Company quality system elements including software/system work products to ensure compliance. This individual will ensure that all system-level project / program work products (e.g., plans, requirements, specifications, tests, test results, traceability, risk management documents, reports) meet Company’s quality, reliability, and compliance requirements. This individual will ensure Design Quality Assurance-driven initiatives meet objectives in delivering highest quality products, with supporting tools and processes.
The Minimally Invasive Therapies Group strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions.
SURGICAL INNOVATIONS sets the standard for Minimally Invasive Surgery (MIS) by creating innovative surgical products and services that focus on obesity and diseases and conditions of the gastrointestinal tract, lung, abdominal wall, pelvic region, and the head and neck.
A Day in the Life
Leading large and complex medical device product development per the FDA design controls starting from design planning through design transfer.
Collaborating with project / program teams to ensure work products comply with Company procedures, acceptable qualitative and quantitative criteria, and global standards, regulations, and guidance.
Working very closely with the development teams during early development of requirements & design (algorithm development and code) and providing feedback to the design based upon SFMEA/Hazard Analysis.
Ability to read software code and participate in detailed technical design and code reviews.
Understanding of the interdependencies of program work products and guide the teams in execution strategy and participating in development, review and approval of all program work products (e.g. plans, requirements, specifications, tests, test results, traceability, risk management documents, reports).
Generating and driving risk management deliverables like SFMEA and Hazard Analysis and preferably experienced in facilitation / execution of the SFMEAs.
Chair cross-functional change control boards.
Utilizes knowledge of various Software Development Lifecycles (SDLC).
Training and coaching cross-functional peers on maintaining compliance to internal and external Quality requirements and regulations in support of the deployment of the different BU strategies and products.
Driving clarity and consistency in documentation.
Leading CAPA projects and assisting post market analysis.
Participating in support of external regulatory audits and inspections.
Driving Process improvement activities.
Work under consultative direction toward predetermined long-range goals and objectives. Assignments are often self-initiated. Determine and pursue courses of action necessary to obtain desired results through consultation and agreement with others rather than by formal review of superior.
Performs other related duties as assigned.
Bachelor’s Degree in Engineering or Science with 4+ years of work experience in Quality and/or Software Development
OR Advanced Degree in Engineering or Science with 2+ years of work experience in Quality and/or Software Development.
Experience working in a regulated industry (e.g., FDA-regulated).
Working knowledge of embedded and mobile application development for medical devices.
Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 62304, IEC 60601-1 and MDD.
Ability to author technical reports, business correspondence and standard operating procedures.
Ability to apply knowledge and work with development and supply vendors to ensure compliance to Company requirements.
Strong verbal and written English communication skills with an ability to effectively communicate at multiple hierarchal levels in the organization.
Ability to multi-tasks, prioritize, meets/exceed deadlines and hold themselves, and others accountable.
Self-Starter with a sharp focus on quality and customer experience.
Excellent growth opportunities.
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About Grey Staffing LLC
With over 30 years in the industry, Grey Staffing, LLC has the experience and know how to fill our clients open positions and help our candidates land their dream job! Grey Staffing is a small, family women-owned and operated staffing firm devoted to our clients and candidates hiring needs. Our goal is to provide our clients with career driven, dedicated and highly skilled professionals. We devise a unique hiring solution for each of our clients, tailored to the available job position. To our clients, you can expect to receive top tier candidates that are vetted and ready to go. To our candidates, we promise to be with you each and every step of the way, providing complete dedication and resource management throughout the entire job search process. You will always receive prompt, individualized attention. Placing temporary, contract, contract to permanent and direct-hire placements in various industries.