Quality Engineer

MGS has an exciting opportunity for a Quality Engineer to join our MGS Germantown Manufacturing team. As a Quality Engineer at MGS, you will assist with the development of quality systems, procedures and controls to ensure that all medical products consistently meet performance and quality specifications in the Germantown Manufacturing facility. The Quality Engineer is a leader and strong technical resource who quickly and effectively resolves quality problems with internal and external customers and suppliers. Below are additional duties and responsibilities: Generates, communicates, and implements ideas and solutions. Demonstrates accuracy and thoroughness in completing tasks timely. Looks for ways to improve and promote quality. Monitor Corrective Action System (i.e. Customer Complaints, Supplier, Internal) Initiate and investigate Customer Complaints according to MGS internal procedure and standards. Record essential information on internal and/or customer-specific documentation, including updating customer portals. Perform investigations using Lean, Six Sigma, and statistical methods to support root cause analysis and corrective actions. Identify gaps and/or trends in systems or processes. Initiate and facilitate the Corrective/Preventative Action process using the appropriate quality tools and input from subject matter experts (SME) to implement sustainable solutions. Update Quality documents according to MGS Change Control procedures, as required. Verify corrective action effectiveness. Drive Non-Conformance Process Evaluate and investigate suspect non-conforming product identified by manufacturing and/or the Quality Lab. Initiate containment activities, as necessary, with Customer Service and Shipping Department. Recommend disposition of product based on thorough investigation and data-driven feedback. Initiate and assist Customer Service with Return Material Authorization (RMA) process. Develop re-inspection, sort, and/or rework instructions for Manufacturing Operators, as required. Collaborate with customer on issuing waiver or deviation documentation and obtain customer approval, as required. Maintain the Quality Management System (QMS). Understand ISO 13485 Quality management systems requirements. Ensure continuing compliance to both internal MGS processes as well as requirements imposed upon MGS by certification bodies, regulatory agencies, and specific customer requirements. Assist in internal, 2 nd party, and 3 rd party audits. Assist with responses and corrective actions for audit findings. Participate in design review, process planning, and failure mode analysis Provide input on evaluation of Key Product Characteristics. Provide input on gaging methods and equipment. Interpret customer requirements including complex blueprints and GD&T call-outs. Review and approve Engineering Change Notifications and Verifications Evaluate for feasibility and implement updates to customer requirements into associated product control plans, pFMEA, Inspection documentation and other related documents. Incorporate industry standard best practices. Incorporate MGS lessons learned. Evaluate, submit and track Supplier Change Notices to customers and/or suppliers. Any other duties as assigned. Manufacturing point of contact for the review and disposition of product quality related questions. Approve Medical Device release for shipment, as required. Perform batch record reviews for medical device prior to release for shipment. Generate Certificate of Analysis, as required. Release product in ERP system based on customer and MGS process requirements. Support Manufacturing process Train Manufacturing and Quality Control personnel on customer requirements, inspection techniques, lessons learned, and rework instructions. Manage product inspection and testing activities. Obtain customer approvals for all required changes based on Quality Agreements. Compile supporting measurement and process performance data, as necessary Assemble supporting documentation package and review for completeness and accuracy Review and approve production documentation updates according to MGS Engineering Change Order process. About MGS As a global provider of healthcare manufacturing solutions, MGS provides the right balance to drive vital innovations: robust end-to-end solutions combined with the strong customer focus and seamless collaboration of an agile partner. That’s why we’re the engineering and manufacturing partner of choice for today’s leading Pharma, Diagnostic and MedTech innovators. Serving customers from 12 strategically located facilities around the world, we transform our customers’ most pressing challenges into innovations that improve lives. To learn more about MGS, please visit . Experience and Skills A qualified Quality Engineer candidate would fulfill these requirements: BS in Engineering, Quality, or related technical field is preferred. Experience in a quality engineering role within a regulated manufacturing environment (medical device a plus). Understanding of quality standards and regulatory requirements: ISO 9001, ISO 13485, 21 CFR Part 820. Understanding of best practices for cleanroom gowning and cleanliness requirements for manufacturing within a cleanroom. Experience with Microsoft Office products – Excel, Word, PowerPoint Greenbelt Certification is a plus. Demonstrated experience in driving continuous improvement projects and using quality tools (e.g., DMAIC, 8D, PFMEA, SPC, MSA, DOE). Excellent interpersonal, communication, and presentation skills. Equal Employment Opportunity MGS Mfg. Group is committed to providing equal employment opportunity to all applicants and employees regardless of their race, creed, color, religion, gender, age, national origin, disability, military service, protected veteran status, genetic information, sexual orientation, gender identity, transgender status, or any other characteristic protected by federal, state or local law. We are strongly committed to this policy and believe in the concept and spirit of the law. The information you provide below is optional and your resume will be given the same consideration regardless of your answer to the following questions. Male Female I Decline To Answer Hispanic or Latino (Persons of Mexican, Puerto Rican, Cuban, South or Central America, or other Spanish culture or origin, regardless of race) White or Caucasian (Not Hispanic or Latino) - Persons having origins in any of the original peoples of Europe, the Middle East or North Africa. Black or African American (Not Hispanic or Latino) - Persons having origins in the black racial groups of Africa. Asian (Not Hispanic or Latino) - Persons having origins in the Far East, Southeast Asia or the Indian subcontinent including Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand and Vietnam. Native Hawaiian or Other Pacific Islander (Not Hispanic or Latino) - Persons having origins in Hawaii, Guam, Samoa or other Pacific Islands. Two or More Races (Not Hispanic or Latino) - All persons who identify with more than one of the above five race categories. I Decline Veteran Status Disabled veterans; Recently separated veterans; Active duty wartime or campaign badge veterans; Armed Forces service medal veterans. I identify as one or more of the classifications of protected Veteran listed above #J-18808-Ljbffr