Supplier Process Engineer

Our Work Matters At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. The Impact You Will Make The Supplier Process Engineer assists in the oversight, evaluation, and qualification of all supplier related activities, including outside processes and production. Additionally, this individual identifies and implements Continuous Improvement opportunities for the manufacture of supplied materials. Role Responsibilities Designs, executes Supplier Process Engineering related protocols; and summarizes studies to ensure consistency of data production and compliance with MMT specifications, medical device regulations and current Good Manufacturing Practices. Responsible for coordinating and oversight of Corrective and Preventive Actions related to Quality events at the suppliers. Coordination and implementation of supplier change notifications, supplier process changes. Responsible for assisting in creating all applicable process documentation to guarantee production processing consistent within validated parameters. Capable of singular project management (within the realm of Supplier Process Engineering) for smaller scope Supplier Process Engineering Plans. Issue’s data, memos, presentations, and reports concerning Supplier Process Engineering projects or areas of interest. Evaluates equipment or process problems (at suppliers as needed) and executes testing to determine possible causes or solutions; assists in executing process capability studies of new equipment/tooling. Assists in ensuring product development activities have all necessary Supplier Process Engineering support. Interacts with outside testing laboratories and provides Supplier Process Engineering assistance where needed on specific issues. Coordinate with QCD lab execution of supplier related protocol execution. Basic Qualifications BS in an Engineering related field 2 years pharmaceutical, laboratory, manufacturing, or Quality Engineering related experience in a medical device/component field. Willingness to travel domestically and globally as needed (15-20% travel). Preferred Qualifications Certified Quality Engineer, Six Sigma training and Lean Manufacturing training desired but not mandatory. Thorough knowledge of cGMPs. Good working knowledge of associated industry and regulatory guidance documents; FDA guidelines, ISO standards, ASTM standards, etc. Excellent knowledge/understanding of protocol acceptance criteria and capable of determining appropriate Corrective action/Preventative Action (CA/PA) for recommendation to management.                                                                                                                                                                      #LI- Remote

Salary : $72,500 - $95,900