The Senior Quality Engineer will play a pivotal role in site process improvement activities and operations support for our Dispensing products. Reporting to the Quality Engineering Manager, duties include: management and approval of process validation studies, active participation in non-conformance investigations and leading process improvement projects. The role also involves the management of continuous improvement projects, and application of SPC to current production processes.
- Drive and maintain cGMP practice within the departments under your quality responsibility.
- Drive root cause analysis of non conformance 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.
- Devise and implement Six Sigma continuous improvement projects.
- Review, analyse and report on field data (complaints, repairs, etc.)
- Support and drive key changes and improvements in manufacturing relating to product quality.
- Carry out Quality and Regulatory Compliance functions within the Quality Engineering Team
- Bachelor's Degree in Engineering field.
- A minimum of 8 years work experience in an ISO 9001/2000 or ISO 13485 environment, coupled with a background in Medical Devices Industry.
- Experience in the preparation of Technical Documentation.
- Supervisory or Project Manager experience.
- Knowledge of Statistical Process Control and Six Sigma methodologies (Greenbelt Certification would be advantageous).
- Experience in CAPA system management.
- A working knowledge of FDA/ISO requirements and managing FDA/ISO audits.
- Experience in process validation,.
- Proven ability of working in a cross-functional team environment.
- Excellent interpersonal and communication skills and high level of computer literacy.