QA Post Market Manager

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.

Are you ready to be part of a dynamic team that's shaping the future of diagnostics? Join Diasorin and become a catalyst for change in the world of healthcare. Apply today and be a part of our exciting journey toward a healthier, more connected world. Together, we can make an impact!

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 Duties and 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
• Representing the PMS activities as a subject matter expert in support of internal and external audits
• 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
• Provides and verifies the application of the Quality Management System ensuring the adequacy and updating of Quality System with respect to the regulatory and quality requirements
• 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 for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire.

Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance or accommodation during the application process, please contact the North America Talent Acquisition Team at hrtalent@diasorin.com or 1-800-328-1482 to request an accommodation.

The above job description is intended to describe the general content, identify the essential functions, and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.

Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations.

Please note that offers of employment at Diasorin may be contingent upon successful completion of a pre-employment background check and drug screen, subject to applicable laws and regulations.

This position is not eligible for partnership with a third-party search firm vendor without expressed, written consent from the Diasorin Human Resources Department.