Quality Engineer

Trelleborg Medical Solutions is seeking a Quality Engineer to join the Delano, MN team. Responsible for the development and administration of a Quality System compliant to FDA and ISO requirements, including the utilization of optimal, cost-effective lean manufacturing processes and methods for new and existing projects including inspection, test and label control operations. Working with internal and external customers supports, quality and continuous improvement using appropriate tools, project leadership.As a valued team member with Trelleborg, you will enjoy:Competitive compensation: Plus, bonus opportunities!Generous benefits package: Includes health, dental, vision, STD, LTD, life, 401k, paid time off, tuition reimbursement, and more!Clean work environment: Enjoy working in a very clean and climate-controlled environment every day!Greater opportunity for impact: You will impact the production of life-saving devices.Growth and advancement: Join a global company that loves to promote from within and allows for advancement. Qualifications:Required:4-year degree in quality, engineering or any related field7 + years in a regulated manufacturing environment Knowledge and experience with GMPISO Standards: ISO 90009001, ISO 13485, and FDA 21CFR 82011 (4210211 as applicable)Certified Six Sigma YellowGreenASQ Certified Quality Engineer andor AuditorClass I, II, andor III Medical device manufacturing experienceDesired• 2+ years in a manufacturing environment in a technical support role • ASQ Certified Quality Engineer• Formal Six Sigma Yellow Green belt trainingResponsibilities:Quality Engineer Expectations:Supports internal audit program as necessary.Supports customer complaint (CC) and RMA system per procedures. Performs investigations, supports determination of the disposition of returned goods, determines re-inspection requirements, determines corrective and preventive actions (CAPA), issues complaint reports, supports completion of customer CAPAs, and approves to close. Looks for trends to determine actions to decrease number of CCsMaintains Non-Conforming (NC) system per procedures. Performs investigations, participates in MRB (Material Review Board) activities, supports determination of the disposition, determines re-inspection requirement, supports determination of correctionscorrective actions and approves to close. Looks for trends to decrease number of NCs and provide feedback to managementMaintains corrective and preventive action (CAPA) system per procedures. Initiates and performs root cause analysis. Uses statistical and capability analysis to solve problems. Implements and verifies CAPAsPerforms trend analysis of CAPA, NCM, ComplaintCustomer Feedback, Risk Management activities, Audits, etc. and presents periodic reports for management review. Assesses Design and any associated activities for manufacturability.Adheres to the company's Quality System (QS), writes and approves QS documentsAuthors and executes Quality Plans for Quality Management Systems and Organizational Objectives projects.Support Engineering, Manufacturing, and Inspection personnel in design, methods, tooling, validations, and other areas related to the control of product municates with customers on complaints, process changes, clarification of specifications, completing customer documents, and other projects as neededConducts studies including Gauge R&R's to develop inspection methods and test equipment. Creates measurement system programs, when necessary.Establishes inspections and sampling procedures to ensure the control of quality at the most economical costs.Creates, reviews and approves Equipment Qualifications, Process, Cleaning, and Software Validation, pFMEA and other documentation as necessary.Participates in customer and ISO audits.Salary range: Starting at $73k and up based on experience

Created: 2025-02-21