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Quality Engineer

Kindeva Drug Delivery
Lexington, KY Full Time
POSTED ON 12/27/2024
AVAILABLE BEFORE 2/27/2025
Kindeva is a leading global contract developer and manufacturing organization (CDMO) with delivery platform experience expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch, and Nasal Spray Technologies. The Lexington location develops, manufactures, and commercializes prescription nasal spray products and is experiencing increasing continuous growth. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture more tomorrows. Kindeva is passionate about helping you realize the full potential of your career! We have the vision to see what’s possible, the expertise to make it happen and the agility to overcome any challenge along the way. We're currently seeking a Quality Engineer that will be responsible for leading and driving the quality efforts in development and marketed products for Kindeva. This person will be the quality team member working with cross functional teams to progress our key product platforms. Key responsibilities will be to drive continuous improvement methods, support complaints, ensure and support needed for design, process and specification changes, qualify suppliers, technical problem-solving skills, and work closely with our customers across our global organization. Job Responsibilities Driving existing product quality enhancement through use of continuous improvement methods and tools, such as: Six Sigma, Product and Process Understanding (PPU), Design of Experiments (DOE), Customer Quality Index (CQI) and Quality at the Source  Leading quality efforts and supporting marketed products Supporting and interacting with customers through complaint investigations, resolution, and trending Ensuring the commercialized product design intent and product integrity is retained as materials, processes, methods, and specifications change Supporting change as it relates to design changes inspired by quality improvement, source of supply changes, or cost reduction efforts  Key responsibilities will include working closely with customers on product requirements, interacting with multiple functions on product development activities, qualify new suppliers Required Skills & Experience Bachelor’s degree from an accredited university in engineering, science, supply chain, business, or related field. 3 years’ relevant work experience Preferred Skills and Experience Experience working in a regulated industry Excellent verbal and written communications skills Strong computer skills Ability to analyze data and develop effective reporting metrics Skilled in technical problem-solving Ability to work in a team structure Excellent interpersonal and organizational skills to interface with global organization   Benefits   Kindeva offers a comprehensive benefits package and resources for employees.   #LI-Onsite

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