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
Support and guarantee the adequateness and the fulfillment of design control process for development of new products and raw materials, as well as related design changes,

in compliance with company procedures and mandatory regulatory requirements with particular attention to the requirements.
Help and support such activities while ensuring that applicable standards and procedures are followed. Participate in Project teams, representing Quality groups and ensuring that Design Control requirements are met.
Contribute and support risk management process, since development of products and processes and in case of changes, including timely update of product and process risk management reports.
Support and ensure that validation activities are well documented and performed.
Cooperate with functions to ensure that processes and procedures comply with quality standards (ISO and GMP).
Key **Responsibilities**:
Ensure that appropriate procedures are established to support Design Development processes.
Support the various phases of product development to guarantee compliance with company procedures and mandatory regulatory requirements.
Review Design Control projects about Instrument (hw and sw), to ensure formal and substantial compliance of project documentation;
Support verification and validation activities to ensure that they are well established and compliant with the regulations.
Verifies the correct preparation of documentation in the context of projects of competence
Collaborate in the drafting, review and approval (as appropriate)

of documentation relating to the projects under her/his responsibility and provide technical support for Regulatory assessments about instrument development project.
Ensure correctness of the documentation related to IVD instrument that shall be submitted to competent authorities
Contributes to the drafting and verification of risk assessments pertinent to the entrusted projects, and to keeping the product risk documentation updated including risk plans, and reports and assisting with all FMEAs to ensure compliance
Collaborates with the departments and with the Regulatory Affairs in preparing the documentation to support the registrations
Collaborates on Quality System updates relating to product/instrumentdevelopment and collaborates on updates relating to processes and changes.
May participate in audits by external and internal bodies assisting in corrective and preventive actions and verifications of effectiveness checks arising during the audits.
Provide training in relation to the areas of expertise
Contributes to impact assessment and verification of change plans with risk analysis skills
Perform assigned tasks in accordance with applicable Environmental Health and Safety (EHS) regulations and Company EHS policies. Violations of EHS regulations or policies will be handled in accordance with the established Company disciplinary process.
May manage other quality duties as requested
Education, Experience, and Qualifications
University Degree or Professional qualification of an equivalent or higher standard, preferably scientific, life sciences discipline and technical with knowledge of biomedical, HW (mechanical, hydraulic, electrical and electronic) and SW aspects.
2 to 3 years related experience in the health care and sciences industry, preferably with diagnostic, me

Molecular Quality Development Associate - System Integration

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