Sr. Quality Engineer

Overview About QTS QTS offers critical end-of-line services for medical device OEMs including finished device assembly, packaging and sterilization management. QTS is part of the Cretex Medical family of companies. Learn more at www.qtspackaging.com and www.cretexmedical.com. Responsibilities Senior Quality Engineer Ideal Candidate Profile QTS is currently seeking an experienced, energetic, responsive and well-organized full-time Sr. Quality Engineer who will be responsible for providing quality assurance support for manufacturing. This position will also be responsible for the definition, implementation, and improvement of quality related practices and will provide technical guidance and measurement methodologies support. Senior Quality Engineer Job Summary Customer facing quality representative for the development project, complaints, and customer feedback. Develop and execute inspection methods; TMV/MSA protocols and reports, facilitate PFMEAs; resolve discrepant material issues and create and maintain quality document such as control plans and inspection documents and plans. Act as the quality interface for a production team in responding to customer complaints using failure analysis, development of corrective and preventative actions and trend analysis. Conduct internal audits, support external audits by regulatory bodies and customers, including closing out audit findings, create audit finding reports and determine proper corrective and preventative actions. Coach and mentor Quality Engineer levels, I, II, and III. Subject matter expert in one or more areas of the ASQ (American Society for Quality) QE BOK (Body of Knowledge). Lead and participate in large company-wide projects providing quality recommendations. Partner with sister companies to implement best practices. Support validation activity of processes, equipment, and metrology. Ensure business systems are implemented, maintained, and functioning properly. Qualifications Senior Quality Engineer Skills and Experience Bachelor’s Degree in Mechanical, Industrial, or in another Engineering or Physical Science. 10 years of experience in engineering in a regulated industry manufacturing setting. Knowledge of quality systems, regulatory requirements, and industry standards. Ability to consistently achieve short and long-term business results. Demonstrate leadership skills. Experience with ERP and quality systems. Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher). Clear and effective verbal and written communication skills. High attention to detail and good organizational skills. Ability to work in a fast-paced team environment. Desirable Criteria & Qualifications Continuing Education; including participation in local chapters, associations, and/or organizations. What Is It Like to Work for QTS? At QTS, we are passionate about quality as the services we provide have a direct impact on the…