Reporting to Quality Engineering Manager (Quality Assurance department), the Quality Engineer is responsible to support, maintain, and facilitate the Product Quality of the assigned Product Lines in the entire Product Life cycle, Design and Production, by means of the applicable Quality System elements, leading the related Risk Management System and updating the key Quality documentation such as Risk Management Files.
During the design development phase and/or during design change:
- Ensure compliance to the design control procedure
- Ensure that process validation procedures comply with regulation
- Review design verification/validation protocols and reports and investigate the cause of V&V failures
- Support the project manager and the team in preparing the design reviews
- Support the project manager and the team in defining DHF and OMR structure
- Maintain Risk Management files during all the design phase
During production and post-production phase:
- Ensure that process validation procedures comply with regulations
- Review process validation planning, protocols and reports and investigate the cause of V&V failures
- Take disposition decision on nonconforming products identified in production
- Evaluate the risk posed by the observed NC on products already distributed; generate the risk assessment (HHE) and propose Stop Shipment and/or FSCA.
- Own CAPA process and trend data to identify opportunities for CAPA and manufacturing process improvements.
- Initiate and lead CAPA whenever it makes sense
- Identify opportunities of quality improvements in the production area and supervise implementation of the improvement plan
- Conduct Risk Management activities ensuring the update of risk assessments throughout product life cycles, and ensure compliance with the documented policy and all applicable regulatory requirements for the assigned product families
- Conduct internal audits and audit to supplier in case of need
KNOWLEDGE AND SKILLS:
- Strong interpersonal skills
- Shall perform routine work with minimal supervision
- Ability to learn independently and to transfer knowledge from one context to another.
EDUCATION & EXPERIENCE:
- BS in Engineering, electronic or mechanical
- Five or more years’ experience in an FDA-regulated environment.