Job Description
embecta is a global diabetes care company that is leveraging 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 join us? A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our employees can fulfill their life's purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program - which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components - is designed to support the varying needs of our diverse and global employees. In this role the Shift Quality Engineer ensures quality engineering support for daily manufacturing operations, collaborating with the Quality Engineering team and Shift QC Leads to meet business quality standards. The position follows a 7am-7pm schedule on a 4-day rotating basis, with occasional night shift coverage as needed. 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, moulding, assembly, packaging sterilization, warehouse) and attend departmental and other meetings as appropriate. Preparation of relevant work sheets and execution of final inspection tests and line clearance verification. Release batches in SAP from packaging to sterilization and final release. Complete DHR reviews and batch releases. Provide GMP guidance in case of rework and/or inspection protocols. Line clearance verification. Complete Product Quality Testing Ensure that maintenance records and process adjustments records are maintained and captured in real time. Ensure all CAPAs under your responsibility are completed in compliance with all regulatory and procedural commitments. Participate in the Change Control Process. Liaise with relevant personnel regarding flow of product through QC department and other issues that arise Preparation, review and approval of technical documentation. Manage and provide support with ongoing changes and continuous improvement projects Perform training as required Ensure the smooth running of functions under your control Review, analyze and report on relevant customer complaints and institute corrective actions Any other reasonable duties which may be required by management from time to time Educational Requirements: Third level qualification in a Science/Engineering discipline Relevant Experience: Strong knowledge and application ISO 9001/2000 or ISO 13485 environment. Demonstrable experience in the preparation of Technical Documentation. Understanding of Statistical Process Control and sampling techniques and standards Experience with SAP and Trackwise is beneficial Good experience in CAPA system management, incident report and MRB Working knowledge of general validation activities Experience in complaints analysis and reporting A working knowledge of FDA requirements and managing FDA audits. Proven ability of working in a cross-functional team environment. Excellent interpersonal and communication skills. High level of computer literacy. embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.