What are the responsibilities and job description for the Quality Engineer position at Kindeva Drug Delivery?
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.
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