Production
4 giorni fa
**Position**
Production-
- **Employer**- Steelco S.p.A- ** Location**- STEELCO S.p.A.- Via Balegante 27, Riese Pio X (TV)- ** Department**- Production- ** Type of work**- full time (8.00 - 17.00)- ** Type of contract**- tempo determinato- o indeterminato-
- La risorsa sarà inserita all’interno dell’Ufficio Commerciale Italia e si occuperà dell’analisi edella predisposizione della documentazione amministrativa e técnica per la partecipazione alle gare e ai bandi di concorso, in conformità alle caratteristiche tecniche ed economiche dell’azienda.
- How you will contribute-
- In this raie you will support the Technical Manager with the creation of all technical documentation as well as with other quality management activities, such as complaint management, CAPA management, vigilance reporting and SOP creation and monitoring.- Your main responsibilities will include:
- Assist in handling complaints, CAPA, and vigilance issues, ensuring timely closure to meet quality KPls.
- Support the development of medicai chemical product specifications and farmulation assessments with contract manufacturers.
- Assist in creating legally compliant documents, including User Requirement Specifications, Labels, Post Market Surveillance, Risk, and Design History.
- Manage and update product specifications, including reviewing incoming goods specifications (CoA/Labels).
- Handle partner requests and ensure timely submission of international product registrations.
- Develop SDS according to REACh requirements and align technical documentation with marketing materials and claims.
- Assist in internal and external audits, ensuring compliance with QMS standards.
- Participate in supplier qualification processes to maintain regulatory and quality compliance.
- Support training program development and identify opportunities far process improvements in quality systems.
- Assist in managing design changes and product lifecycle updates to meet regulatory expectations.- What you need to succeed-
- Oegree (chemistry or other science) with experience in the field of medical devices.
- Additional qualifications regarding MOR, Risk assessment, SOS creation or H&.S is an advantage.
- Experience with ISO 13485:2016, ISO 9001 :2015, Risk Management (ISO 14971 :2019) and Complaint/CAPA management.
- Expertise in EU MOR &. UK MOR Technical Oocumentation (Clinical Evaluation knowledge is an advantage) and SOS creation under REACh.
- IT competent with knowledge of SOS software (preferably Excess).
- lntegrity and a proactive mindset with a strong sense of ownership and responsibility.
- Strong ability to assess challenges and implement effective solutions- Why join our team-
- Work in an international, fast-growing industry that makes a real impact on healthcare.- 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.
- Additional benefits of joining the company include a strong team ethic, Birthdays off, opportunities far growth and working far a small but impactful-
- Ready to make an impact?
to improve healthcare worldwide
- APPLY NOW
- In case of dossiers from employment agencies, the terms and conditions far the placement are negotiated individually in each case. General conditions are not accepted.
- **Informativa ai sensi del Nuovo Regolamento UE n. 679/2016**
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