Quality Operations Leader

Bd Medical

Dun Laoghaire, Dublin South

BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. BD leads in patient and healthcare worker safety and the technologies that enable medical research and clinical laboratories. Does it sound exciting? Good news, we are hiring! We are now looking for a highly talented Quality Operations Leader to manage all quality issues in the StriveTM (Swatch) area, once the project moves from qualification phase to operational phase. The Quality Operations Leader will manage the Strive quality team,and have responsibility for the investigation, resolution and/or escalation of quality issues as they arise. Project Management duties will include management and approval of process validation studies, oversight and management of all projects work linked to StriveTM and Mario process/ product improvements, liaising with key stakeholders, and managing the area in a compliant manner. This role is based in our brand-new facility on Pottery Road, Dun Laoghaire. This person will be responsible for Day to day Leadership/Management of Quality Team. Manage and develop the team through involvement, delegation, and regular reviews of performance as established in IIGs (goals), with specific focus on the following. We are looking for passionate people who aren’t afraid to take smart risks, innovate and are eager to make things happen. This is an amazing opportunity to join a fast-growing company with room to grow your skills and experiences in a complex, matrix and international organization. Your responsibilities will include: Responsible for ensuring adherence to all BD, external and appropriate regulatory requirements; Management of all quality systems elements relating to BD StriveTM direct production support such as the non-conformance system, incident reporting system and customer complaint analysis, etc; Support production personnel in relevant continuous improvement activities (Six Sigma); Prepare and Maintain documentation in compliance with appropriate regulatory requirements; Coordinating the activities of the Quality resources allocated to other support function (e.g., Incoming Materials, Packaging, Warehouse and Sterilization) to ensure optimal efficiency and compliance with all regulatory requirements; Ensure all CAPAs under your responsibility are completed in compliance with all regulatory and procedural commitments; Work with supplier quality and BD R&D Andover to resolve product related issue; Supporting key changes and improvements in manufacturing relating to product quality; Drive root cause analysis of non-conformances with the department subject matter experts; Preparation, review and approval of technical documentation; Ensure all CAPAs under your responsibility are completed in compliance with all regulatory and procedural commitments. The successful candidate will have at least 5 years’ experience in in an ISO 9001/2000 or ISO 13485 environment, coupled with a background in Medical Devices/Pharmaceutical Industry. Experience in the preparation of Technical Documentation. The ideal candidate will have a solid educational background and proven ability of working in a cross-functional team environment. Knowledge of Statistical Process Control and Six Sigma methodologies (Greenbelt Certification would be advantageous).Experience in CAPA system management. A working knowledge of Iso-13485 and FDA requirements, and experience hosting/ managing FDA audits would be advantageous. You will be familiar with process validation, terminal sterilisation and working in a clean room environment. The ideal candidate will have excellent interpersonal and communication skills and high level of computer literacy. You can look forward to a rewarding career, great benefits package, collaborative working and opportunities to expand your skills in this fast moving, dynamic and agile business. If you’re a team player who is passionate about healthcare and we’ve just described your career aspirations, then please click on the APPLY button. Interested in a career with BD, but this position doesn’t fit your skills and experience? Join our external EMEA Talent Community here: http://bd.tal3nt.community/ This job originally appeared on RecruitIreland.com.

1962 days ago