Job Title: Quality Engineer
We are a global company empowering brands that make a difference in the world.
We are looking for a talented individual to join our team and contribute to our success.
Key Responsibilities:
* Support the New Product Introduction (NPI) team, participating in design transfer meetings and providing input to Design FMEA (Failure Mode and Effects Analysis).
* E nsure Critical-to-Quality (CTQ) attributes are cascaded from design inputs to inspection plans.
* Develop and implement measurement systems (gages) for ongoing product inspection.
* Plan and execute Test Method Validation (TMV) to ensure accurate and reliable test results.
* Collaborate with cross-functional teams to drive process improvement and automation implementation.
* Develop and maintain control plans aligned with product classification, potential defect types, and defect frequency.
* Review and release Production Risk Management documentation to ensure compliance and quality standards.
* Prepare reports and presentations for internal and external stakeholders.
Requirements:
* Bachelor's degree in a technical field (Biomedical/Mechanical/Automation engineering) or equivalent experience.
* Minimum 3 years of experience in a manufacturing environment (Medical Device, pharmaceutical, automotive preferred), or an equivalent combination of education and experience.
* Experience working in a highly regulated environment (knowledge of ISO13485, CFR 21 part 820, MDR) is essential.
* Strong understanding of Six Sigma techniques and inferential statistical analysis is required.
* Proficiency in MS Office, Agile, and Windchill is a plus.
* Fluent communication skills in Italian and English are mandatory.
* Knowledge of German is an asset.
Your Skills:
* Excellent organizational skills, with attention to detail and discipline.
* Independent thinker with problem-solving skills.
* Persistent and resilient, with the ability to overcome business and personal challenges.
* Proactive approach to task completion.
* Effective communication skills at multiple levels of the organization.
* Creative problem-solver with the ability to simplify complex situations.
* Ability to plan, schedule, and perform moderately complex engineering projects to evaluate, select, and adapt or modify standard manufacturing techniques, procedures, and criteria to increase efficiency.
* Flexible and adaptable to changing priorities and deadlines.
* Precise and accurate in all aspects of work.