Corporate Quality Assurance Senior Auditor - Saluggia, Italy - ITA 2021-031

Job Title

Corporate Quality Assurance Senior Auditor

Job Facts

Organizational Area
Country / State
Place of work
Home/Office based
Office based

Professional Family: 

  • Quality
Reporting To
Corporate Compliance & Quality System Senior Manager

Kind of contract

Full Time / Part Time
Full Time
Permanent / Temporary
Job ID
ITA 2021-031

Job Scope

Your Mission

The mission of Corporate QA Senior Auditor is to provide unbiased, responsive, professional, collaborative, independent and objective Quality audits, in according to Corporate Procedures, by bringing a systematic, disciplined approach to evaluate and improve the compliance to the QMS International Standards, Rules, Directives and Regulations, and to the Corporate policies and procedures within the DiaSorin Group (Manufacturing sites, Subsidiaries, Corporate Functions) and DiaSorin Suppliers.

Main Responsibilities

Your Contributions

The Corporate QA Senior Auditor examines and evaluates findings about the quality system's adequacy and deficiencies.
He/she is responsible at Corporate level for:
- preparing and revising the Annual Master Plans about Internal and Corporate Suppliers Audits.
- conducting periodical planned Internal audits, in order to verify that all the procedures are correctly implemented and respected within the DiaSorin Group.
- conducting planned audits at Corporate Suppliers sites subject to DiaSorin controls.
- creating and/or managing the Audit documentation (Plan, Report, Action Plan).
- making recommendations on possible correction/improvement.
- following through with the audit, or local CAPA Plans, until correction of all the non conformities, assuring the documentation of the corrective actions and verifying the corrective actions implementation.
- reviewing auditing procedures, inspection documentation, reports and other documents related to the audit and quality assurance
- supervising the sites' Quality Improvement Plans, and the cross-assessments based on the management of the outcome of Third Parties Inspections.
- Manage the Corporate QS documentatio

Qualifications Experience Personal Strengths Mobility

Bachelor degree or a professional qualification of an equivalent or higher standard, preferably scientific and technical. Qualification as Auditor of Quality Management System (for Internal and Supplier Audits)
A certification such as Third Party Auditor of QMS would be appreciated

A minimum of 4-5 years work experience in the health care and science industry, preferably with diagnostic, medical devices or pharmaceutical Companies (preferably in an FDA regulated environment), - Minimum of 2-3 years of solid experience in QMS Audit (external or internal)

Technical Competencies

Knowledge of relevant IVD medical device technologies and related design and manufacturing processes, knowledge of Quality Management System and current International and European regulations/standards to respect to IVD MD.

  • Personal characteristics: integrity, ethics, confidentiality, sincerity, diplomacy, open-mind, sense of observation, perspicacious, persevering, resolute, self-confident.

  • Abilities: excellent attention to detail and organization skills, ability to work equally as well on your own as in a team, excellent interpersonal skills, be organized and flexible, excellent written and verbal communication skills, ability to work under pressure and meet tight deadlines, good problem solving and decision making.

  • Computer skills: seasoned experience using GMail, Google Apps, Excel, Word, MicroSoft Project, PowerPoint proficiency

Fluent spoken and written English. A second European language is a plus
Travel Availability
Available to travel within Europe Countries, to USA, Asia and where needed for business purposes.
Relocation Availability
Training Required

Specific training courses in relation to:
- Quality Management Systems Auditing certification (preferably Third Party auditor)
- MDSAP (Medical Device Single Audit Program)


We Offer You

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