Exactech
Supplier Quality Engineer
Exactech - Gainesville, Florida, us, 32635
Work at Exactech
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Overview
Department:
Quality Location:
Gainesville, FL Description A Supplier Quality Engineer works with internal customers to support supplier selection, approval, auditing, and monitoring. They serve as a liaison between suppliers and internal teams to drive supplier quality improvements. The role involves providing technical support for supplier assessments, change notifications, and corrective actions. The engineer is responsible for implementing quality programs and projects, requiring professionalism, knowledge, creativity, and flexibility. Key Responsibilities Ensure compliance with FDA 21CFR Part 820 regulations and ISO-13485 standards. Represent Exactech and its QA processes, fostering cross-functional partnerships with suppliers. Facilitate supplier selection, development, qualification, approval, and monitoring. Act as the supplier liaison to resolve quality issues effectively. Lead supplier audits, visits, and conference calls. Participate in continuous improvement projects focused on supplier quality. Identify non-conformance trends, support investigations, and establish inspection/test procedures. Monitor quality performance of suppliers in collaboration with Purchasing and QA. Establish Quality Agreements and Terms & Conditions with suppliers. Justify and process supplier Deviation Requests. Manage Supplier CAPAs and participate in First Article Inspection (FAI) activities. Develop and report metrics, reports, and review presentations. Support verification and validation activities, including IQ, OQ, and PQ protocols. Monitor and report on Supplier CAPA triggers. Assist team members as needed. Skills, Knowledge, and Expertise Education: Bachelor’s Degree required; Master’s Degree preferred. Experience: At least 5 years in Supplier Quality Management within the medical device or regulated industries (e.g., Automotive, Aerospace). Strong knowledge of quality systems and risk management (ISO 13485, ISO 17025, ISO 14971, 21 CFR Part 820, Part 11). Ability to interpret technical drawings and GD&T. Experience with process and product validation (IQ, OQ, PQ). Understanding of Failure Mode and Effects Analysis (FMEA). Technical Skills: Knowledge of Statistical Techniques, including SPC, and experience implementing controls. Effective team collaboration skills.
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Quality Location:
Gainesville, FL Description A Supplier Quality Engineer works with internal customers to support supplier selection, approval, auditing, and monitoring. They serve as a liaison between suppliers and internal teams to drive supplier quality improvements. The role involves providing technical support for supplier assessments, change notifications, and corrective actions. The engineer is responsible for implementing quality programs and projects, requiring professionalism, knowledge, creativity, and flexibility. Key Responsibilities Ensure compliance with FDA 21CFR Part 820 regulations and ISO-13485 standards. Represent Exactech and its QA processes, fostering cross-functional partnerships with suppliers. Facilitate supplier selection, development, qualification, approval, and monitoring. Act as the supplier liaison to resolve quality issues effectively. Lead supplier audits, visits, and conference calls. Participate in continuous improvement projects focused on supplier quality. Identify non-conformance trends, support investigations, and establish inspection/test procedures. Monitor quality performance of suppliers in collaboration with Purchasing and QA. Establish Quality Agreements and Terms & Conditions with suppliers. Justify and process supplier Deviation Requests. Manage Supplier CAPAs and participate in First Article Inspection (FAI) activities. Develop and report metrics, reports, and review presentations. Support verification and validation activities, including IQ, OQ, and PQ protocols. Monitor and report on Supplier CAPA triggers. Assist team members as needed. Skills, Knowledge, and Expertise Education: Bachelor’s Degree required; Master’s Degree preferred. Experience: At least 5 years in Supplier Quality Management within the medical device or regulated industries (e.g., Automotive, Aerospace). Strong knowledge of quality systems and risk management (ISO 13485, ISO 17025, ISO 14971, 21 CFR Part 820, Part 11). Ability to interpret technical drawings and GD&T. Experience with process and product validation (IQ, OQ, PQ). Understanding of Failure Mode and Effects Analysis (FMEA). Technical Skills: Knowledge of Statistical Techniques, including SPC, and experience implementing controls. Effective team collaboration skills.
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