NC Quality Systems Engineer

Description

Position Summary: The NC Quality Systems Engineer ensures compliance with the Quality Management System (QMS), participates in audits, and manages Nonconformance (NC) records. Key Highlights: 1. Participates in internal, external, and third-party quality audits. 2. Collaborates in the investigation and disposition of nonconforming products. 3. Leads continuous improvement initiatives and serves as a QMS subject matter expert. Job Description and Detailed Responsibilities The NC Quality Systems Engineer is responsible for ensuring compliance with the BD MMS Quality Management System. This role involves participation in audit programs (both internal and external) and collaboration with manufacturing sites and leadership within the EMI Center. The role is accountable for overseeing the intake, review, and resolution of Nonconformance (NC) records. **General Functions and Responsibilities** 1\. Participates in internal, external, and third-party quality audits. 2\. Coordinates with Quality Engineering, Manufacturing, Supply Chain, and Supplier Quality to ensure effective investigation and disposition of nonconforming products/materials. 3\. Maintains data integrity and audit readiness for all NC records. 4\. Provides guidance and training on proper NC initiation, documentation, and closure. 5\. Contributes to the updating of NC procedures, forms, and work instructions. 6\. Supports coordination of documentation and execution of Global Holds. **Specific Roles and Responsibilities** 1\. Verifies that electronic disposition in ERP systems aligns with physical inventory status. 2\. Generates and maintains metrics, including Aging, cycle time, disposition trends, and recurrence. 3\. Prepares executive-level presentations and detailed meeting minutes summarizing key metrics, trends, and the status of Global Holds and Nonconformance (NC) records. 4\. Independently manages routine tasks with meticulous attention to detail. 5\. Ensures accuracy, completeness, and consistency of data across systems and reports. 6\. Leads continuous improvement activities at BD EMI and serves as a Subject Matter Expert (SME) for Quality Management System (QMS) processes within the scope of this position. 7\. Identifies systemic patterns or issues and recommends improvements. Experience and Requirements 1\. Bachelor's degree in engineering or related field. 2\. 2–3 years of experience. 3\. Advanced English proficiency. **Skills and Competencies** 1\. Knowledge of FDA, ISO, and ANSI regulations and standards (e.g., ISO 9001, ISO 13485, ISO 14971, 21 CFR Part 820, QMSR). 2\. Proficiency with Microsoft Office Suite, especially Excel. 3\. Familiarity with ERP/QMS systems (e.g., SAP, Trackwise). 4\. Excellent interpersonal and communication skills, along with strong organizational and detail-oriented abilities. 5\. Preferred certifications include Total Quality Management, Six Sigma, or similar. 6\. Knowledge and experience in data trending, analysis, and improvement. Benefits * Benefits in accordance with the Federal Labor Law (LFT) * Life insurance * Savings fund * Retirement savings fund * Medical expense insurance * Guaranteed profit-sharing * On-site medical services **Number of Openings** 2 **Department** Quality **Employment Type** Permanent **Work Modality** On-site **Shift** Day **Work Schedule** Full-time **Working Hours*** Full-time **Education Requirement** Bachelor’s degree with professional title **Willingness to Travel** No