Quality Assurance Specialist

Steelco and Belimed have joined forces to lead the way in advanced cleaning and sterile workflow solutions. This partnership is powered by our united strengths: a dynamic product range, relentless innovation, utmost reliability, and an unmatched commitment to customer satisfaction. As SteelcoBelimed, we “Innovate with confidence”, as we set new industry standards to meet our customer’s needs offering high-quality products and comprehensive services for Infection Control and Life Science.

Your Activities

Maintaining the QMS in compliance with relevant standards by supporting process managers in implementing applicable requirements, participating in company projects, drafting procedures and operating instructions, monitoring and controlling processes, and identifying opportunities for improvement.

Tasks & Responsibilities

• Conducting and participating in internal audits and managing the results.
• Supporting the QA Manager in managing second- and third-party audits and their results.
• Periodically analyzing and supporting in the definition and coordination of CAPA actions related to the QMS.
• Supporting the management of the Change Control process related to the QMS.
• Issuing QMS documents and managing their distribution.
• Supporting functions managers in defining, monitoring, and continuously improving processes in accordance with relevant standards, and in drafting QMS documents within their scope of responsibility.
• Supporting the conduct of audits and assisting in the selection, evaluation, and monitoring of suppliers.
• Support in activities related to customer complaints.
• Support the QA Manager in analyzing training needs regarding quality requirements, and in coordinating and conducting training and awareness activities for company departments.
• Provide support and monitoring for customer projects where applicable.
• Participate in company projects to assess risks and their impact on the QMS and manage related activities.

Your Profile

• Regulatory and quality expertise: GMP (Good Manufacturing Practices), ISO 9001 and ISO 13485.
• Excellent knowledge of Adobe Acrobat and Microsoft 365, particularly Word, Excel, Visio, Power BI and SharePoint.
• Previous experience in project management and executive reporting.
• Advanced level of English, both written and spoken.
• Previous experience in conducting internal and/or external audits.
• Strong team-oriented and collaborative mindset.
• Excellent public speaking skills.
• Strong organizational skills and ability to manage priorities.
• Flexibility, reliability, and strong mediation skills.

Required experience

Previous experience in this role is required, preferably in international companies in the pharmaceutical/medical industry or similar sectors.

Required education

A Bachelor’s degree and/or Master’s degree, or another qualification recognized by the Italian State, in Pharmacy, Engineering, or related fields.

Our Offer

• Work in an international, fast-growing industry that makes a real impact on healthcare and pharmaceutical industry.
• Be part of an innovative and open-minded team.
• Join a company with a strong reputation and long-standing expertise in cleaning and disinfection solutions.
• We offer a people-focused work environment, with dedicated benefits and welfare initiatives.