As a Quality Engineer II, you will be at the forefront of driving excellence in our products and processes. You ll leverage your experience to ensure our life-changing therapies meet the highest standards of quality, compliance, and reliability. This role requires you to be onsite Monday through Friday, providing you the opportunity to collaborate closely with cross-functional teams in a fast-paced, hands-on environment. Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality. Must Have: Minimum Requirements To be considered for this role, please ensure the minimum requirements are evident in your applicant profile. Bachelor s degree required in a related engineering discipline (mechanical, biomedical, manufacturing, etc.) Minimum 2 years of relevant experience, or advanced degree with a minimum of 0 years of relevant experience. Bachelor s degree with a minimum of 2 years of relevant experience, OR an advanced degree with a minimum of 0 years of experience Nice to Have Experience reviewing technical documentation Previous process validation experience (including installation qualifications, process characterization, operational and performance qualifications) Previous experience with developing, executing, and analysis of Test Method Validations Previous experience with Master Validation Records and Risk Management documentation (including DFMEA and PFMEA) Strong written and verbal communication skills Strong critical thinking and analytical skills CAPA NCMR knowledge If interested and qualified, please submit your resume to careers@dr-group.com or visit our website to apply: www.dr-group.com (job #6582) For additional job openings, follow DRG on Social Media! Web: www.dr-group.com LinkedIn: https://www.linkedin.com/company/development-resource-group?trk=companylogo Twitter: https://twitter.com/DRGMN