A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux provides diagnostic solutions which determine the source of disease and contamination to improve patient health and ensure consumer safety.
Our teams working across our digital transformation and information technology areas are literally changing healthcare through technology. Their various expertises are serving innovations for patients and business. Development of new solutions (hardware and software) as well as building qualitative data and insights contribute to the constant improvement of public health.
Come and join a family-owned global company with a long-term vision, and a human-centered culture.
SCOPO PRIMARIO E OBIETTIVO GENERALE DEL RUOLO:
Quality Engineer cooperates with the Operations QA Manager and the Site Manager to reach the Company quality objectives and to be a strong support to them. He/she is accountable for the implementation and maintenance of effective Quality Systems in accordance with applicable standards. QE participates and provides guidance to quality improvement teams on tools, techniques and management systems for quality assurance, compliance, and continuous quality improvement. Ensures products (including services) are developed, manufactured, tested and delivered according to established procedures that will assure that they meet all quality requirements.
- Provide support in the documentation of Quality System in the areas of Firenze Operations, auditing, quality trends, training, validation, corrective and preventive actions, process control, documentation control, etc. to ensure compliance with regulatory requirements.
- Participate to the achievement of the Company quality policy and objectives, by facilitating all the activities in the Operations area related to Quality and by cooperating to proper application of all Corporate and Local Procedures.
- Provide support on QA-related activities in writing and / or local implementation of the relevant QMS procedures; training of personnel on procedures.
- Manage Nonconforming Products by involving the required personnel and manage/follow up the resolution of problems identified in-house by ensuring that adequate feedback and information on the requested investigations are provided and necessary corrective/preventive actions are taken and duly implemented by those responsible for product/process quality.
- Coordinate manufacturing process validation and manage process risk analyses.
- Participate as Project Contributor in development projects, develops and implement project Quality Plan (as necessary), facilitate and develop quality-engineering deliverables, participate to the updating of Design History File and Device Master Record (as necessary).
- Support the supplier approval and monitoring process, ensuring the maintenance of the quality level defined by bioMérieux QMS procedures.
- Manage and animate the Change Review Boards for supported products.
- Participate to item masters approval process and manage QA related parameters in the ERP.
FORMAZIONE, ESPERIENZE E COMPETENZE RICHIESTE PER IL RUOLO:
- A scientific degree (preferably engineering) and at least a 3 years work experience in a relevant industry in R&D/Manufacturing, including at least 1 year in quality.
- Theoretical and practical knowledge of Quality Management System, preferably achieved in industries working according to at least ISO 9001 standard (pharmaceutical, fine mechanical, certification body, testing lab, etc.).
- Knowledge of quality standards such as ISO 9001 and 13485.
- Knowledge of US 21 CFR Part 820 and related CFR, 98/79/EC IVD directive and main other regulations such as Canadian regulation.
- Ability to work in an international context.
- Strong communication skills and leadership.
- Proficiency in English, spoken and written.
- Use of general IT software/system and knowledge of main office automation, in particular Excel spreadsheets.
bioMérieux welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.