Product Quality Engineer Firenze

Product Quality Engineer
Firenze
Toscana, Firenze

To access all opportunities available in the company globally Reporting to the Site Quality Manager, the 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 updating it following manufacturing and post-sales information.

He/She coordinates and ensures changes on processes and products are managed in compliance with bioMérieux QMS, including the management of deviations and quality events.

The 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, 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.

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 in the achievement of the Company quality policy and objectives, by facilitating all the activities in the Operations area related to Quality and by cooperating in the 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, develop and implement project Quality Plan (as necessary), facilitate and develop quality-engineering deliverables, participate in the updating of Design History File and Device Master Record (as necessary).

Manage and animate the Change Review Boards for supported products.

Participate in 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 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.

TRAINING AND SKILLS REQUIRED A scientific degree (preferably engineering) and at least 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.

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