Orange Park, Florida, United States
- New suppliers' selection, Monitor supplier performances, Supplier scorecard -New Product Introduction Deliverables -Auditing QMS, ASL, and suppliers -Nonconformances, RCA, RCCA, CAPA, CAR, SCAR -Equipment and process validation IQ, OQ, PQ -Risk Management PFMEA, DFMEA, SPC -FAIR, Software testing, APQP, PPAP
· Extensive knowledge of device regulations including but not limited to design control, risk management, product transfer to manufacturing, product and process control, audits management, supplier management. · Manage supplier qualification and maintenance program, supplier changes and evaluate associated risk to product and QMS. · Manage quality agreements and ensure adherence to requirements. · Manage supplier corrective action report (SCAR) program, review SCAR response for acceptability. · Manage audit program (internal and external). · Risk Management PFMEA, DFMEA, SPC. · FAIR, Software testing, APQP, PPAP.
• Work with internal and external stakeholders to comply with applicable FDA and EU MDR regulatory requirements. • Lead the supplier qualification and disqualification process. (Supplier Selection) • Manage Quality Management System (QMS). Monitor and update the Approve Supplier List (ASL). Monitor and update supplier performances. • Owner of the supplier audit program. Prepare the annual supplier audit schedule. Conduct supplier audits and drive for resolution of audit nonconformances via SCAR system. • Generate and ensure complaint completion of Quality deliverables such as Design reviews, Engineering Change Orders, Design & Development Plans, Risk Management, User Needs, Design Input Requirements, Test Methods, Design Review, Design V&V, Usability Testing, SW Validation, Process Validation, Packaging, Labeling, Statistical sampling plans, etc., Support NCMR and CAPA activities. • Knowledge of Equipment and Process Validation IQ, OQ, PQ. Protocols. • Provides suggestions into risk management system like DFMEA, PFMEA. • Intimately familiar with PPAP, APQP, FMEA, PFMEA, SCAR, CAR, SCORE CARD principles and systems. New product development, design verification and validation, design history file reviews, reliability planning and execution and process validation protocols and reports. • Participate in assessing and creating suppliers score card. • Develops strong internal relationships with team members and external with customers, suppliers, and other cross functions to support business objectives. • Coordinating process improvement, cost reduction and or defect reduction projects. • Perform First Article Inspection per AS9102 to ensure manufacturing process capability. • Strong working knowledge of 21 CFR Part 820 and ISO 14971, 13485, 9001. Knowledge of government compliance and quality control regulatory standards, like RoHS, REACH, SCIP, Prop65.
· Support the Ear, Nose, Throat (ENT) and the Orthopedics Supplier Quality Engineering Group.
- Working with suppliers to design inspection system and resolve quality issues. - Applied PPAP, APQP, FMEA, PFMEA, SCAR, SCORE CARD principles and systems. - New product development, design verification and validation, design history files reviews, reliability planning and execution and process validation. - Participate in supplier selection. - Participate in assessing and creating supplier score card. - Perform First Article Inspection per AS9102 standards to ensure manufacturing process capability. - Perform audits as needed. Steer root cause and corrective action presentation. - Review nonconformance data for accuracy. Focus on process robustness using process control measures like SPC, A3, 8D, DMAIC. - Provide concessions / MRB / GD&T. - Dispositions, approvals and closures of NCR's
· Audits to ensure vendors continue to work in compliance with company Confer with vendors to qualify product and work with supplier quality to qualify vendors. · Working with suppliers to design inspection systems and resolve quality issues. · Working knowledge/familiarity IPC J-STD-001, IPC-A-610, and G.D. and T Standards · Intimately familiar with PPAP, APQP, FMEA, PFMEA, SCAR, CAR, SCORE CARD principles and systems. New product development, design verification and validation, design history files reviews, reliability planning and execution and process validation. · Participate in assessing and creating suppliers score card. · Develops strong internal relationships with team members and external with customers, suppliers, and other cross functions to support business objectives. · Coordinating process improvement, cost reduction and or defect reduction projects. · Perform First Article Inspection per AS9102 to ensure manufacturing process capability. · Reviewing incoming supplies and products from vendors, conduct tests and assessments to check for defects and ensure quality. · Visiting vendor facilities and observing the manufacturing environment to review and assess their procedures. · Perform routine Quality Audits on 1st Tier and Sub Tier supplier quality as needed. · Perform regular quality control and federal standards. Internal auditing and training as needed. Experience in Electrical standards (NEC, NFPA, IEEE, UL, and IEC) engineering drawings/ layout/ blueprints electrical schematics Electrical products - Like switch gear, Switch board,
• Creation of Root Cause Corrective Action (RCCA). • Experience Perform First Article Inspection per AS9102. • Accurately documents result of inspections and testing per program criteria. • Effectively communicates non-conformances in writing and verbally. • Maintain all controlled document files and test records in a timely and accurate manner. • Develop and select methods for analysis, testing and audits for manufacturing readiness. • Evaluate problems and makes initial recommendations for possible corrective action. • Provide day to day support to manufacturing operations. • Supports engineering and value stream teams in problem solving and continuous improvement. Program process and documentation. • Provide concessions / MRB support to steady state programs and lead improvements to eliminate customer escapes by deploying robust root cause and corrective action. • Dispositions, approvals, and closures of NCR's. • Assist in development of new standards repairs for non-conformances. • Develops quality criteria to support supplier selection activities. • Analyzes non-conformance trends to evaluate effectiveness of corrective actions. • in systematic problem-solving methodology A3, 8D, DMAIC. • Contractual, company and regulatory requirements. • Conducts root cause analysis and develops dispositions for design non-conformances. • Develops and implements corrective actions. • Develops and implements product or process improvements. • Provides interpretation of complex requirements. • Audit quality management system. Experience with GD&T and CMM. • Experience in Electrical standards (NEC, NFPA, IEEE, UL, and IEC) engineering drawings/ layout/ blueprints electrical schematics Electrical products - Like switch gear, Switch board, More duties as required by management.