Quality Systems Lead - Compliance, Audits & Training

DiaSorin S.p.A.; Saluggia; On-site; EUR 30,000 - 37,000; Full time

Benefits offered by this job

Free canteen

Well-being program (Feel Good – Diasor

Supplementary pension

Supplementary healthcare coverage

Job summary

DiaSorin S.p.A. in Italy is seeking a Quality System Specialist to develop and maintain a QMS in line with ISO and regulatory requirements for medical devices and IVDs. You will ensure documents are updated and train staff in QMS practices.

Joining DiaSorin means contributing to a global diagnostics portfolio, collaborating across functions, and supporting audits by subsidiaries and customers while upholding cGMP standards and strong quality culture.

Qualifications

• Degree in scientific or technical disciplines.
• At least one year experience in similar or equivalent positions in chemical/pharmaceutical or medical device industries, or experience in the production/quality control of medical devices.
• Familiarity with Office programs such as Excel, PowerPoint, and Word.
• Strong verbal and written communication skills.
• Solid problem solving and analytical skills.
• Solid interpersonal skills, including ability to negotiate and influence without authority.
• Strong communication and interpersonal skills with ability to work well in a high pressure environment.
• Strong competency in Customer Focus and Driving for Results.
• Fluent knowledge of the English language.

Responsibilities

• Develop and maintain a Quality management system in line with the regulatory and mandatory requirements applicable to Medical Device and IVD (including ISO 9001, ISO 13485, cGMP, IVDR ecc) through existing and new documentation.
• Ensure that all relevant documents are updated, revised and modified in accordance with quality management system requirements.
• Spreads awareness of quality management system to all levels of the company.
• Spread, through appropriate trainings, a culture of continuous improvement and good manufacturing practice across the company.
• Cooperate with other functions to ensure that new projects and processes are in compliance with all internal and external requirements.
• Determine, through planned internal audits, whether the Quality management system is conform to the applicable requirements and effectively implemented and maintained.
• Support Subsidiaries, Distributors and customers providing required product documentation.

Skills

Fluent English

Strong communication

Problem solving

Interpersonal skills

Customer focus

Driving for results

Education

Degree in scientific or technical disciplines

Tools

Microsoft Office (Excel, PowerPoint, Word)

Job description

DiaSorin S.p.A. in Italy is seeking a Quality System Specialist to develop and maintain a QMS in line with ISO and regulatory requirements for medical devices and IVDs. You will ensure documents are updated and train staff in QMS practices.

Joining DiaSorin means contributing to a global diagnostics portfolio, collaborating across functions, and supporting audits by subsidiaries and customers while upholding cGMP standards and strong quality culture.