The Senior Quality Engineer will play a pivotal role in site process improvement activities. Reporting to the Quality Engineering Manager, duties will 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, application of SPC to current production processes, liaison with key customers and supervision of the QA/QC laboratories.
- Coordinating the activities of the Quality resources allocated to the Incoming, Packaging, Warehouse and Sterilization departments to ensure optimal efficiency and compliance with all regulatory requirements.
- Drive and maintain cGMP practice within the departments under your quality responsibility.
- 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.
- Become an active member of the site internal audit team, liaising with Regulatory auditors.
- Devise and implement Six Sigma continuous improvement projects.
- Act as customer liaison contact for given key customers.
- Review, analyze and report on relevant customer complaints.
- 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
- A minimum of a bachelor's degree is required. The ideal candidate will have a degree in an engineering discipline.
- A minimum of 5 years of experience in a quality role. Prior work experience in an ISO 9001/2000 or ISO 13485 environment is desired.
- A background in the medical device or pharmaceutical environment is a plus.
- 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 requirements and managing FDA audits.
- Experience in process validation, sterilization and working in a clean room environment would be advantageous.
- Proven ability of working in a cross-functional team environment.
- Excellent interpersonal and communication skills and high level of computer literacy.