Quality Assurance Specialist

Job Requisition Name
Quality Assurance Specialist

Job Requisition No
VN8157

Work Location Name
Italy - Rome

Worker Basis
Full Time

Worker Type
Employee

Applications Close Date
May 31, 2025

Purpose
The QA Specialist supports the development and maintenance of processes, review and update of quality system procedures and controls, ensuring that the performance and quality of the quality management system conforms to regulation, standards and agency guidelines. Supports the review and analysis of quality performance and processes and develops corrective actions for recurring discrepancies. Supports the preparation and submission of appropriate indicators and reports to the site Quality Management and/or the company as part of the management review process.

Key Responsibilities

1. Supports the management of all site specific activities, initiatives and programs to achieve quality objectives;
2. Interfaces with various departments such as production, R&D, customers and suppliers to ensure compliance with the Quality System, assists in determining responsibilities and solutions when required;
3. Participates in and performs internal audits and supports in the preparation and execution of external audits;
4. Monitors compliance with cGMP practices;
5. Maintains compliance with the BVI Quality Management System; supports in the management and maintenance of the effectiveness of the quality management system; facilitates awareness of quality, regulatory and customer requirements throughout the organization;
6. Supports the application of the CAPA process, in particular the completion of the various corrective/preventive actions related to local and global quality systems;
7. Assists in the development and continuous improvement of SOPs and work instructions;
8. Supports the implementation of process improvement and/or compliance initiatives, including eQMS;
9. Encourages strong problem-solving methodologies;
10. Participates in sharing best practices, initiatives/ideas, and results across the company;
11. Performs other tasks identified while performing this role.

Qualification

1. Master's Degree - Mechanical, Electronic, Biomedical Engineering or related field - or equivalent education and experience;
2. 1-3+ years of relevant experience preferably in the Medical Device environment/industry;
3. Good knowledge of English language;
4. Knowledge of Quality Management Systems, preferably as defined by 21CFR820 and ISO 13485;
5. Experience with all aspects of third-party auditing activities (e.g. Front Room / Back Room, Non-conformance Closure, etc.);
6. Experience planning, implementing and maintaining an electronic QMS solution preferred;
7. MS Office and management SW applications;

Company
BVI is refocusing the future of vision.

As one of the fastest-growing, diversified surgical ophthalmic businesses in the world, our purpose-built portfolio of trusted brands includes: Beaver (Knives and Blades), Visitec (Cannulas), Malosa (Single-Use Instruments), Vitreq (Vitreoretinal Surgical Products) and PhysIOL (Premium IOLs), and spans more than 90 countries.

We've set our sights on touching the lives of millions of patients affected by conditions such as cataracts, refractive error, glaucoma, retinal disease, and dry eye. Unburdened by legacy or bureaucracy, we have developed our strategy around a simple concept - taking pride in delivering innovative solutions for our physicians and patients, based on their needs. We trust and empower our associates to make decisions and solve problems because collaboration drives us. Valuing agility, simplicity, and transparency, we stay committed to listening to our customers, delivering for our patients, and keeping the future in focus.

Learn more at www.bvimedical.com