QA Post Market Manager

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Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 years, we've earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world.
Our broad offering of diagnostic tests and Licensed Technology solutions, made available thanks to ongoing investments in research, positions us as the player with the widest range of specialty solutions in the sector and identifies us as the "Diagnostics Specialist."
Why Join Diasorin?
**Impactful Work**: When you join Diasorin, you become part of a team that's dedicated to improving lives. Your contributions will directly impact patient care, making a meaningful difference in the world.
**Global Reach & Innovation**: Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world, expanding your horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry.
**Diverse and Inclusive Culture**: We believe in the strength of diversity, and our inclusive culture reflects this commitment. We value your unique perspective and offer a supportive, collaborative environment where everyone can thrive.
**Join Our Team**: If you're passionate about innovation, diversity, and making a positive impact on healthcare, Diasorin is the place for you. We're looking for passionate and talented individuals who are ready to embrace new challenges and drive healthcare solutions forward.
Job Scope
**The QA Post Market Manager is responsible to**:
Oversee all activities related to the complaint handling process from QA standpoint




Manage the post market surveillance activities to ensure that medical devices continue to be safe and well-performing and to ensure corrective actions are undertaken when necessary
Collect and evaluate experience gained from medical devices that have been placed on the market and to identify the need to take any action or to highlight opportunities to improve.
Key **Responsibilities**:
Managing the Post-Market Surveillance process and related deliverables to ensure compliance with all applicable internal and external requirements
Ensuring timely and accurate processing for PMS data collection, plans and periodic reporting
Organizing PMS team, to plan and gather all the information needed for the creation of PMS reports and Plans
Overseeing the generation of Post-Market Surveillance plans during the product development.
Maintaining up-to-date knowledge on global regulatory requirements for PMS, vigilance and reporting
Ensuring the communication of PMS result to product SME, PD, production, customer care and Top Management
Overseeing Complaint processing in compliance with FDA, Health Canada, EU, China and other country specific vigilance regulations
Managing Field Corrective Action Activities and Adverse Event reporting to ensure compliance
Consistently striving to improve quality according to the highest standards
Cooperating with other function to ensure that the process and procedures are in compliance with quality standard (ISO and GMP)




providing training and spread the knowledge of the Quality System at all company Ievels
Performing internal and external audit
Collaborating with technical groups to identify product improvement opportunities
Collaborating in the definition of the correct risk assessment on the product/process.
Education, Experience, and Qualifications
Degree in scientific disciplines
Knowledge of regulatory / compliance requirements applicable to in vitro diagnostics / medical devices
At least five years of Medical Device / -IVD or chemical-pharmaceutical industry experience in similar position
Use of Office pack
Project Management
Risk management and related tools
Post Market Surveillance
Working knowledge of FDA Medical Device Regulations including Quality System Regulation 21 CFR Part 820, provides and verifies that the Quality Management System meets the requirements of lSO900l, 1S013485, US FDA QS Regulation (21CFR820) and the Medical Device Regulation (SOR I 98-282) of Canada
Strong analytical skills including trend and statistical analysis Project Management.
Strong verbal and written communication skills
Solid problem solving and analytical skills
Marked ability to identify risks associated with a product/process issue
Solid interpersonal skills, including ability to negotiate and influence without authority
Ability to supervise team members or to work as part of a team
Ability to manage complex projects and multiple projects (5+) simultaneously
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
Diasorin is an equal opportunity employer. All qualified applicants will receive consideration

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7hjq6c