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Job Description
**Quality Operations Team Manager**
**Empower people with diabetes to live their best life through innovative solutions, partnerships, and a passion for quality excellence.**
Embecta is a global diabetes care company that leverages its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships, and the passion of more than 2,000 employees around the globe.
**Why this role?**
• Be part of a team that values your opinions and contributions
• Empower you to bring your authentic self to work
• Fulfill your life's purpose through the work you do every day
• Learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture
**Responsibilities:**
• Manage the activities of Quality Inspectors to ensure optimal efficiency and compliance with all regulatory requirements
• Drive root cause analysis of non-conformances with relevant personnel and ensure corrections are implemented before starting back to production after a quality issue
• Drive and maintain cGMP practices across all operational departments under your quality responsibility
• Release batches in SAP from packaging to sterilization and final release
• Complete DHR reviews and batch releases
• Liaise with relevant personnel regarding flow of product through QC department and other issues that arise
• Review, analyze, and report on relevant customer complaints and institute corrective actions
**Requirements:**
• Degree in a Science/Engineering discipline
• Previous work experience in an ISO 9001/2000 or ISO 13485 environment, coupled with a background in Medical Devices/Pharmaceutical Industry or industries such as automotive, food production, or other high volume manufacturing experience
• Experience of preparing technical documentation and a good knowledge of Statistical Process Control and Six Sigma methodologies
• Experience in CAPA system management and a working knowledge of FDA requirements and managing FDA audits
• Good knowledge of SAP and Trackwise
• Excellent basic IT Skills, e.g. MS Office
• Manage and provide support with ongoing changes and continuous improvement projects
• Previous experience of working in process validation and a clean room environment is a benefit
• Enthusiastic about working within a cross-functional team and have excellent interpersonal and communication skills and enjoy the team dynamic