Quality Engineer
Trelleborg Medical Solutions is seeking a Quality Engineer to support the development, implementation, and maintenance of a Quality Management System compliant with FDA regulations and ISO standards. This role partners with cross-functional teams, customers, and suppliers to ensure product quality, regulatory compliance, and continuous improvement. The Quality Engineer will drive quality initiatives for new and existing products, utilizing Lean Manufacturing principles and quality tools to enhance manufacturing, inspection, testing, and labeling processes while supporting operational excellence and customer satisfaction.
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 CCs
- Maintains 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 corrections/corrective actions and approves to close. Looks for trends to decrease number of NCs and provide feedback to management
- Maintains 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 CAPAs
- Performs trend analysis of CAPA, NCM, Complaint/Customer 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 documents
- Authors 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 quality.
Required:- 4 year degree in quality, engineering or any related field
Desired:- 2+ years in a manufacturing environment in a technical support role
- ASQ Certified Quality Engineer
- Formal Six Sigma Yellow/ Green belt training
- Experience with ISO 13485
Compensation package range: $90,000-$115,00 DOE
