Product Quality Engineer (Sost. Maternità)

PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB

Product Quality Engineer ensures that products are manufactured, tested, and delivered according to established procedures that guarantee all quality requirements are met. He/She is accountable for managing the manufacturing process risk analysis, coordinating the risk management group and approving the outputs, taking care of update it following manufacturing and post sales information. He/She coordinates and ensure changes on processes and products are managed in compliance to bioMérieux QMS, including the management of deviations and quality events.

Product Quality Engineer also manages the complaint handling process at the Florence site, including the management of investigations and trending related to technical complaints on instruments in compliance with standards and regulatory requirements, following bioMérieux Corporate and Local procedures. He/She reviews and audits complaint files for content and coding, analyzes field trend data for potential investigations, and decides when to involve technical experts from Florence R&D and support functions. He/She tracks investigation progress, maintain complaint files, document activities, and provide status updates, ensuring effective implementation of corrective actions, providing feedback to GCS or GiCS on investigation results for customer responses and report on the status of investigations.

MAIN ACCOUNTABILITIES

• 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; perform 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).
• Manage and animate the Change Review Boards for supported products.
• Participate to item masters approval process and manage QA related parameters in the ERP.
• Manage complaint handling process effectively on the manufacturing site according to the applicable procedure and to ensure all the complaint files are appropriately documented and filed.
• Manage investigations and trending regarding the control and assessment of product quality, manufacturing and market acceptance consistency in order to improve product quality.
• Participate in audit and regulatory inspections.
• Support the appraisal of the continuous effectiveness of the facility quality system in terms of quality levels, nature of manufacturing quality problems, customer complaints. Initiate, implement and/or recommend changes to procedures, policies, and specifications when appropriate.

Support manufacturing activities as needed.

TYPICAL STUDIES - EXPERIENCE, SKILLS AND QUALIFICATIONS

• 1. Studies - Experience:
• A scientific degree is preferred 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 ISO 13485.
• Knowledge of US 21 CFR Part 820 and related CFR, Regulation (EU) 2017/746, MDSAP.
  2. Skills and qualification:
• Ability to work in an international context.
• Strong communication skills and leadership.
• Proficiency in English, spoken and written.
• Use of general IT software/systems and knowledge of main office automation, in particular Excel spreadsheets.