Quality Engineer Position Available In Volusia, Florida
Tallo's Job Summary: As a Quality Engineer, you will manage Corrective and Preventive Actions (CAPA), conduct supplier quality audits, and lead New Product Development initiatives. Responsibilities include establishing quality standards, analyzing quality data, and assisting with process validation. Experience in quality engineering, CAPA management, and knowledge of ISO standards are essential. The role is based in a manufacturing environment with opportunities for growth and a family-oriented atmosphere.
Job Description
Job Title:
Quality Engineer Job Description As a Quality Engineer, you will be tasked with owning and managing Corrective and Preventive Actions (CAPA), executing supplier quality audits, and participating in supplier selection. You will conduct internal and external audits for quality management, design experiments for various validations, and perform root cause analysis for quality issues. Responsibilities Own and manage CAPA system, including addressing customer complaints and communicating actions and updates. Lead and participate in New Product Development, working closely with cross-functional teams to identify and mitigate quality risks. Establish quality standards for products and processes, suggesting modifications to prevent defects. Act as an Internal Auditor for both Florida and Nicaragua facilities. Collect and analyze quality data with Statistical Process Control (SPC) support. Assist with process validation, capabilities, and improvements. Review and approve proposed manufacturing and specification changes. Define manufacturing requirements and processes using Lean Manufacturing concepts. Analyze product, customer, and regulatory requirements to determine necessary tools, fixtures, and equipment for projects. Oversee and update processes and procedures to ensure compliance and improvements. Participate in Kaizen Events and follow-up implementation. Essential Skills Experience in quality engineering and CAPA management. Proficiency in Design of Experiments (DOE) and Root Cause Analysis. Knowledge of 21 CFR 820 and ISO standards, especially
ISO 9001.
Understanding of Lean Manufacturing principles. Familiarity with sterilization, bio-compatibility, RF welding, and extrusion processes. Additional Skills & Qualifications Experience in quality assurance and supplier quality management. Ability to perform internal audits and supplier audits. Experience in the medical device field is advantageous. Work Environment This role is set in a manufacturing environment where you will work primarily in an office setting, with regular involvement in managing projects on the shop floor. The company offers a family-oriented atmosphere and a good benefits package, providing ample growth opportunities in a highly regulated industry.
