Quality Engineer

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.

EEOC Statement

Kindeva Drug Delivery/Summit Biosciences is an equal opportunity employer and does not discriminate against any employee or applicant for employment based on race, color, religion, national origin, age, gender, sex, ancestry, citizenship status, mental or physical disability, genetic information, sexual orientation, veteran status, or any other characteristic protected by applicable law. We are committed to creating a diverse and inclusive workplace that values and supports all employees.

California residents should review our Notice for California Employees and Applicants before applying. 
 
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