Quality Technician

Quality Technician

Requirements

• High School Diploma or GED
• Effective Oral/written Communication
• Ability to work as part of a team / Teambuilding
• Independent thinking / Self Driven
• Decision Making Ability
• Troubleshooting / Problem Solving
• Quality Systems Knowledge
• Computer Skills / Microsoft Office
• Good Documentation Practices
• Basic Math Skills

Responsibilities

• Work with Quality Engineers, Quality Technicians, Operations Leaders, CI Line Leads, and other Operations associates to document, contain, disposition, and release nonconforming material.
• Act as a mentor to operations associates to develop a sound understanding of quality plans and the importance of adherence to controlled documents and Good Manufacturing Practices (GMPs).
• Perform training to operations associates on the procedures, instructions, inspection techniques, measuring devices, and sampling plans.
• Maintain a daily presence on the manufacturing floor, proactively assisting manufacturing associates to ensure they are operating per procedures, validated parameters, and to ensure all documentation is complete and accurate.
• Review completed Device History Records (DHRs) for accuracy and completeness.
• Provide support for nonconformances, including setting up product rework and controlling pallet traffic.
• Perform inspections and tests as per the applicable SOPs, SWIs, protocols, sampling plans, or Quality Engineer direction.
• Evaluate inspection methods for improvement opportunities and assist with creation of new inspection methods or other work instructions.
• Actively participate in Continuous Improvement teams and activities, including 5S, Department Shift Start-Up meetings, blitzes, work sessions, etc.
• Work overtime as needed by the department. Work flexible hours as business needs require.
• Timely completion of assigned training activities in C2C.
• Escalate issues as necessary in an effective, timely, and appropriate manner to the appropriate individuals (peers, Quality Engineers, support teams and management).
• Comply with all local BD quality policies, procedures, and practices through consistent application of sound quality assurance principles.
• Comply with all local, state, federal, and BD safety regulations, policies, and procedures including RCRA Hazardous Waste regulations.

Preferred Qualifications

• Testing and measurement equipment experience.
• Knowledge of Quality Assurance practices and sampling methods.
• Basic computer skills, including BD systems (Datalan, SAP, etc.) and Microsoft Office.
• Experience in medical device manufacturing environment or other regulated industry.