Quality Specialist

Changing lives. Building Careers.

Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.

RESPONSIBILITIES

Process management and business support:

- Review and approve promotional documentation and technical data sheet.
- Support Italian site for products distribution and manage product changes in Agile.
- Support third part logistics subcontractor in making products available for shipment and maintaining compliance with Integra quality and distribution requirements, cooperating to improve processes and performance and managing complaints.
- Support the Logistics team: inspect quarantined products and decide for disposition according to the local regulations. Support audits and manage quarantine / rework requests from the manufacturing sites at the distribution center.
- Collaborate with European and US Quality teams to ensure quality concerns are addressed early in the process and appropriate strategies are developed.
- Organize qualification and periodic evaluation of Italian suppliers.

Quality System:

- Build and maintain the Quality Management System in accordance with corporate guidelines and any other standard/regulation (ISO 13485 among others) as well as ISO 9001 requirements.
- Manage documents in Agile and notify users through the appropriate way.
- Maintain the training matrix up to date.
- Organize and perform Quality Management System training for new hires and ensure proper trainings for the role are completed and recorded.
- Organize and present the Management Review annually, collect the metrics information.
- Manage Italian suppliers (classification, periodical evaluation, documentation )
- Support the Notified Body audits.

Product Compliance:

- Collect the required information from involved departments (Marketing, Sales, EMEA RA ) and provide assessments and assistance in case of changes with regulatory/quality impacts.
- Support the Tenders Department to get documents and data (Declaration of conformity, CE or ISO certificates, labels,) and maintain up to date the documents for non-Integra products.
- Support the complaint process and the field safety corrective actions related to products sold by ILS Italy.
- Manage nonconformities and improvement actions.
- Perform quarterly and annually EEE and batteries declarations according to the local regulation.
- Support Regulatory Affairs team for products notifications to the Italian Ministry of Health database (new products, product and documents update, discontinuation ).
- Audits
- Support any internal and external audits performed on site or at a manufacturing site.

QUALIFICATIONS
- Master (in LifeSciences and/or Quality), Advanced Degree (Engineer, MBA, MPA, MPH, PhD, Pharm D) desirable.
- 2 to 5 years' experience in Quality Assurance functions.
- Understanding of all quality, GxP standards as well as medical devices regulatory requirements
- Strong knowledge of the Medical Device industry and related policies (ISO 9001 standard and EU MDR)
- Organizational skills.
- Fluent in Italian and English
- Strong analytic skills and ability to provide insight into quality issues.
- Experience in Regulatory Affairs is a plus.

BUSINESS TRAVEL
- Travels to EMEA sites according to the need of the sites.
- Regular visits to the Italian distribution center.