Quality Engineer

Within the Quality Assurance team based in Saluggia, as Quality Engineer , you will support the development, manufacturing, release and post market surveillance activities associated with MicroPort CF products manufactured and released by the Saluggia plant. You will also ensure the maintenance of quality KPI, provide prompt support to Operations and enhance system efficiency to guarantee the achievement of the business goals, provide technical guidance to all peers on best practices and regulatory requirements.

Your missions will be as follows

Responsibilities of this position include, but are not limited to, the following:

• Manage autonomously non conformities related to product and processes
• Develop, review and approve quality system procedures
• Complete and/or support in root cause investigation and corrective actions (CAPA)
• Actively participates to internal/external Audits
• Analysis of trends
• Lead or participate in projects (e.g. cost reduction and compliance) providing clear directions to other departments of product Quality and design testing requirements
• Lead or participate in the creation and maintenance of device Risk Management at all stages of the design process and review final technical responses and/or failure investigation reports.
• Maintain up-to-date knowledge of technology development for relevant projects and relative applicable standards.
• Collaborate, review, approve the development of new test methods as appropriate for evaluations of product characteristics.
• Collaborate, review, approve the Validation of the test methods to ensure they are accurate, reliable and repeatable.
• Collaborate, review, approve the process validation strategy for new products to minimize product risks.
• Manage all the Quality related activities to give desired project outcomes in terms of quality and meeting deadlines.
• Actively drive continuous improvement of Quality/design review and ensure compliance with existing specifications.

Your profile

• Fluent in English language
• Fluent Italian language
• Good and effective written and verbal communication skills
• Ability to teach in the areas of competence
• Good collaboration
• Familiarity with medical industry terminology
• Proficiency in Microsoft applications: Word, Power Point, Excel, Outlook
• Knowledge of laboratory techniques and instruments (e.g. destructive/nondestructive analysis, use of microscope)
• Good problem solving skills
• Basic knowledge in the application of risk management tools
• Basic knowledge in the application of statistical techniques
• Basic knowledge in calibration
• Knowledge of ISO 13485:2016, 21 CFR 820, MDR
• Degree in Biomedical, Mechanical or Electronic Engineering (Master degree is preferred)
• At least 2 years of experience in a medical device company and/or GMP ruled company

What do we offer?

• Salary range: 33.000€ - 38.000€
• Permanent full-time contract, CCNL Industria Chimica