Quality Engineer Position Available In Volusia, Florida
Tallo's Job Summary: Quality Engineer will own and manage CAPA's, execute supplier quality audits, perform internal and external quality audits, and conduct design of experiments for validations and root cause analysis. The role involves addressing customer complaints, leading CAPA systems, participating in new product development, and ensuring compliance with ISO 13485 and FDA regulations. The ideal candidate will be skilled in Statistical Process Control, process validation, Lean Manufacturing, and Kaizen events.
Job Description
Description Quality Engineer will be responsible for performing various duties such as owning and managing CAPA’s. Execute supplier quality audits, and supplier selection. Perform internal and external audits for quality management. Quality Engineer will perform design of experiment for various validations and root cause analysis for quality issues. Additional Skills & Qualifications Lead in addressing Customer Complaints including response to customers, communications of actions and updates to CMP processes, product requirements, and procedures. Lead in Corrective and Preventative Action (CAPA) system. High level participation in New Product Development working closely with cross functional teams, including product development, product management and production, to identify and mitigate quality risks. High level experience with CMP product, processes, and procedures. Experienced with
ISO 13485
Standard, and FDA CFR Part 820 regulations Establishes quality standards for products and processes and suggest modifications meant to prevent defects in components or final products. Skilled in collecting and analyzing quality data with Statistical Process Control (SPC) support. Assist with process validation; process capabilities; and process improvements. Review and approve proposed manufacturing and specification changes. Exercise high level judgment to define manufacturing requirements and processes using Lean Manufacturing concepts. Analyze product, customer, and regulatory requirements to determine tools, fixtures and equipment requirements for assigned projects. Oversee processes and procedures against actual practices and update ensure compliance and provide improvement for processes and procedures. Participate in Kaizen Events (Lean) and follow-up implementation.
