Quality Engineer

embecta is one of the largest pure-play diabetes care companies in the world, leveraging its nearly 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of approximately 2,000 employees around the globe. For more information, visit embecta.com or follow our social channels on LinkedIn, Facebook, Instagram and Twitter. 

In this role you will support Quality Operations Team Manager , including

participating in product and process development, investigating

non-conformances, making lot disposition decisions, applying SPC to production, and liaising with key customers. The role also entails coordinating with QA/QC labs, approving process validation studies, managing complaint investigations, engaging in change control processes, adjusting processes, and leading or participating in improvement projects. Additionally, you will prepare, review, and approve technical documentation.

Responsibilities:

• Managing the activities of the 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 (Incoming, assembly, packaging, warehouse) and attend departmental and other meetings as appropriate;
• 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.

Experience and Education

• 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 also welcome !
• Experience of preparing technical documentation and a good knowledge of Knowledge of Statistical Process Control and Six Sigma methodologies (Greenbelt Certification would be advantageous).
• Experience in CAPA system management and a working knowledge of FDA
• requirements and managing FDA audits.
• Good knowledge of SAP and Track wise.
• 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.

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