QA Auditor 2

About the role

We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. Job Description 1. Job Description A. General Accountabilities A1. Safety and ISO14001 Environmental Accountability Ensure a safe, healthy, and environmentally responsible workplace by following company rules and procedures. Actively participate in identifying and eliminating potential safety hazards and in activities that promote recycling, resource reduction, and environmental sustainability. A2. Safety & Health Accountability Safety and health are important to BD. You are expected to observe all assigned safety programs and training in a timely manner to ensure work tasks are performed in accordance with safety guidelines and SOPs. A3. Good Manufacturing Practice (GMP) Accountability Adhere to GMP rules and procedures at all times. A4. SOP/SWI Compliance Apply Standard Operating Procedures (SOP) and Standard Work Instructions (SWI) in daily operations. A5. Code of Ethics Comply with the BD Code of Ethics at all times. A6. Incident Reporting Report all incidents/accidents, near misses, and deviations from plan. Participate in investigations when required. A7. Quality Incident Reporting Report all quality incidents, near misses, and non-conformances from SOPs or specifications. Participate in investigations when required. B. Operational Tasks B1. Incoming Material Inspection Perform visual, graphical and dimensional inspections on incoming materials and components. Verify Certificates of Conformance (COC), Certificates of Analysis (COA), test reports, and related documentation against purchase specifications and drawings. Ensure inspections comply with Good Documentation Practice (GDP), GMP and established SOPs. Complete inspections within required lead times to support production demand. Identify abnormalities immediately and escalate when necessary. B2. Supplier Feedback & Material Release Coordination Communicate discrepancies in incoming material documentations / products to suppliers promptly. Provide clear, accurate, and timely feedback on detected issues. Ensure all discrepancies are addressed before releasing materials. Highlight and escalate delays that may impact production. Maintain professional communication with internal and external stakeholders. B3. Non-Conformance Handling Process non-conforming materials in accordance with the Non-Conformance Product Handling Procedure. Assist in supplier's goods defect verification by performing sampling and data collection. B4. Quality Notification & Material Control Raise Quality Notifications (QN) and block and segregate by quarantine of defective materials to prevent unauthorized use. Release materials/components only after verification confirms no quality issues. B5. Record Keeping & Audit Support Maintain accurate, traceable inspection records in compliance with ISO/QMS standards. Ensure proper storage, maintenance, and retention of inspection records. Support document retrieval for audits, customer inquiries, and internal reviews. Duties & Responsibilities B6. Prioritization & Quality Decision-Making Prioritize inspections based on production urgency, criticality, and operational needs. Ensure timely and accurate disposition decisions to prevent production downtime. Apply risk-based thinking for borderline or sample-based evaluations. Maintain high accuracy in measurements, documentation, and reporting. B7. Database & SAP Reporting Update incoming database daily, clearly indicating materials requiring follow-up. Generate weekly SAP reports to ensure all inspection lot is properly captured in database. B8. Internal Coordination Coordinate with internal teams for sample collection and urgent releases. Communicate promptly to avoid delays that could impact production. Escalate material issues that may affect release timelines. B9. Improvement initiatives and supplier qualification projects Participate in supplier qualification projects by assisting in data collection and inspection. Contribute improvement initiatives by optimizing workflow and process through Kaizen submission. C. Supporting Tasks C1. Shift Communication Participate in daily shift change meetings to communicate inspection progress, issues, and priorities. Provide accurate updates to ensure smooth handover between shifts. C2. Continuous Improvement & Tool Support Participate in continuous improvement initiatives. Identify opportunities to enhance work processes, inspection methods, and workflow efficiency. Support calibration and maintenance of inspection tools when required. C3. Sorting & Rework Activities

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