Molecular Quality Development Associate

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

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.

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 Duties and 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.
• 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
• 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 development and collaborates on updates relating to processes and changes.
• 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.
•  Support in the application of Quality Tools such as Risk Management, Root Cause Investigations, and investigation of process and products failures and implement lasting solutions of such failures.
• May manage supplier qualification, procedures writings and other activities in order to ensure that processes and procedures comply with quality standards
• Perform other duties as assigned.

Education, Experience, and Qualifications 

Bachelor’s Degree preferred in an Engineering or life sciences disciplines such as Biochemistry, Chemistry, Microbiology, Biotechnology or Bio-Engineering.

2 to 3 years related experience in IVD, medical, pharmaceutical, or other related industry in Quality department

• Thorough understanding of statistical quality control, statistical process control, Corrective Action Process, and their application manufacturing as a problem identification and resolution tool.
• Knowledge in Advanced SPC, Quality Analysis Tools (e.g. Fishbone) & DOE
• FDA Process Validation Techniques preferred
• Knowledge of QMS requirements, with specialization on design control requirements preferred
• Software product development experience within the IVD environment a plus
• Good interpersonal skills, professionalism
• Ability to work with cross functional teams
• Time management skills and organization skills; Analytical skills; Problem-solving
• Group work orientation
• Ability to apply mathematical operations to such task as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory and factor analysis
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
• Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
• Ability to write reports, business correspondence and procedure manuals.
• Ability to effectively present information and respond to questions from groups of people during meetings .
• Computer skills: seasoned experience using Microsoft Excel, Word, PowerPoint.

Fluent spoken and written English

Travel availability: On demand

Place of work: Bresso

Hybrid work

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.