Job Description
TheQuality Control Manager will reportdirectly to the Head of the Quality Department and will play a key role in ensuring compliance with quality standards.
This position offers the opportunity to work in a structured, international environment, actively contributing to the development and maintenance of the company’s quality system.
Key Responsibilities
- Define and implement Quality Control Plans for the dimensional and mechanical characteristics of medical devices produced during the prototype, pre-production, and release phases, in collaboration with the department heads responsible for development, industrialization, and production;
- Manage the machine programs associated with the measurement equipment used in production and quality control;
- Manage method validation and reliability plans, analyze experimental data, and monitor quality KPIs, as well as support and approve activities related to system/process validation;
- System risk engineering activities using FMEA and technology benchmarking;
- Manage supplier qualification and monitoring, and conduct external audits at suppliers
- Manage deviations and corrective and preventive actions (CAPA)
- Implement quality standards and risk management activities company-wide, in coordination with management
- Participate in cross-functional project teams, providing support and guidance on quality issues
- Provide independent reports on quality compliance
- Support operational staff in implementing quality-related activities in accordance with ISO 13485 and applicable regulations
- Coordinate inspection readiness activities
- Support company staff in the areas of quality and compliance
Requirements
- Bachelor’s or master’s degree in a scientific field (preferably mechanical engineering or materials engineering)
- 3–5 years of experience in roles such as Quality Control Manager or Quality Control Head.
Experience
- Experience in Quality Control, Quality Assurance, and Manufacturing at manufacturing companies (precision engineering or similar)
- Extensive experience in team/resource management
Technical skills
- Knowledge and application of the European standards ISO 13485 and ISO 9001
- Understanding of risk management principles
- Ability to analyze processes and focus on problem-solving
- Proficiency in the main Microsoft Office applications; proficiency in using MES, SAP, BC, and Power BI
Language skills
- Italian and English: good written and spoken proficiency (minimum level B2)
Soft skills
- Ability to work independently and prioritize tasks
- Accuracy, attention to detail, and strong organizational skills
- Proactivity and ease of interaction with partners, suppliers, and external customers.
Certifications (preferred)
This announcement is open to both men and women, in accordance with Laws 903/77 and 125/91, and to people of all ages and nationalities, in accordance with Legislative Decrees 215/03 and 216/03.
Candidates are invited to read the privacy notice pursuant to Article 13 of Regulation (EU) 2016/679 (GDPR). Personal data will be processed exclusively for the purposes of the recruitment process.