Candidate will be responsible for assisting with the implementation of new projects in a manufacturing environment. Duties may include creating and revising work instructions, developing and executing validations, analyzing failures to create corrective actions, pFMEA revisions, working closely with Senior Engineers to develop processes, training users in new processes, and equipment validations. Candidate must have strong communication skills, critical thinking skills, ability to work autonomously and a strong focus on time management. Candidate must be able to work in multiple software systems including Microsoft Office, Agile PLM, SAP and others as needed. Experience with Excel Macros is a plus.Top 3 Technical Skills Required1-3 years of Medical Device industry experience; familiar with FDA 21 CFR Part 820, EU 217/745 (EU MDR); familiar with ISO 13485, ISO 14971, IEC 60601; knowledge of Microsoft Office Applications (Word, Excel, Access, PowerPoint) and Windows OS.Investigation and root cause analysis skills.Process validation, equipment validation and software/spreadsheet validation knowledge.Education Required: Bachelor's.Years of Experience Required: 2-5 years.ResponsibilitiesDevelops, modifies, applies and maintains quality standards and protocols for processing materials into partially finished or finished products.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; performs statistical analysis to assess costs and determine responsibility for products or materials that do not meet required standards and specifications.Ensures corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.May specialize in design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.QualificationsStrong communication skills.Critical thinking, ability to work autonomously, strong focus on time management.Experience with Microsoft Office suite, Agile PLM, SAP, Excel macros.Knowledge of regulatory standards (FDA 21 CFR Part 820, EU MDR, ISO 13485, ISO 14971, IEC 60601).Experience in process validation, equipment validation, and software/spreadsheet validation.#J-18808-Ljbffr