Job Title
Job Facts
Professional Family:
- Quality
Kind of contract
Job Scope
For over 40 years, DiaSorin has been on a mission on five continents to develop, produce and commercialize diagnostic tests for a wide range of clinical areas. Our tests are designed for hospitals and private testing laboratories, in the markets of immunodiagnostics and molecular diagnostics.
We believe in a respectful and supportive workplace that attracts and celebrates the uniqueness of a diverse workforce that represents our community and customers.
Main Responsibilities
This role will serve as the subject matter expert and go-to authority regarding product development, product quality assurance, microbiology (bioburden and environmental monitoring) and asset management.
This role will be continually consulted regarding best practices to ensure that Product Development, Production activities, microbiology and asset management are performed in a compliant manner that supports business roles.
Qualifications Experience Personal Strengths Mobility
7 years in quality, regulatory, compliance manufacturing, operations and/or engineering within the IVD medical device industry
Minimum of 3 years people management experience
10 years in quality, regulatory, compliance manufacturing, operations and/or engineering within the IVD medical device industry
Minimum of 5 years people management experience
Demonstrated knowledge of FDA regulations, ISO 13485, ISO 14971, IVDR, other national and international regulations and standards
Experience with direct contact with FDA and ISO Registrars, IVDR Notified Bodies
Knowledge of environmental monitoring processes
Knowledge of Asset Management – Preventive Maintenance, Repairs, Calibration, etc.
Strong leadership, project management skills and ability to influence others
Strong analytical skills, exceptional writing and interpersonal relationship skills
Competency in the management of Design Controls, Process Controls, Risk Management and Validation (including Equipment, Software and Process)
Competency in environmental monitoring and asset management/tracking related to equipment – procurement, qualification, repair, preventive maintenance, calibration, etc.
Competency in Document and Change Control, Quality Audits, CAPA including Root Cause Analysis, Nonconformance Records management
Understanding of immunoassay principles
Demonstrated organizational, management and communication skills
Establish and maintain procedures and process for Environmental Monitoring
Participate in QMS and regulatory audits, management review, reporting of quality metrics, review of quality records and other major projects to support the organization.
Participate in the Quality Assurance management team to set priorities and policy for the team to ensure support of the organization
Provide leadership to the Product Quality Assurance and Asset Management team, ensuring clear and aligned objectives, supporting employee development, and encouraging collaboration across the organization
This role will be continually consulted regarding best practices to ensure that Product Development, Production activities, Validation, Environmental Monitoring, Bioburden, Risk Management and Asset Management are performed in a compliant manner that supports business objectives
Responsibility for the Risk Management process
Responsibility for site’s Quality Improvement Plan
Oversite/responsibility for the asset management software and tracking system and analysis of related metrics
Oversite of the environmental monitoring and bioburden processes and associated metric reporting
Establish and maintain procedures and process for the handling of Nonconforming Material
Establish and maintain procedures and process for Asset Management, including validation, PM, tracking, qualification
YES
Benefits
Receive a competitive salary and benefits package as you grow your career at DiaSorin. Join our team and discover how your work can impact the lives of people all over the world.
Others Information as per Local Legal Requirements
We are an equal opportunity employer that values diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply.
This contractor and subcontractor shall abide by the requirements of 41 CFR 60-1.4(a), 41 CFR 60-300.5(a) and 41 CFR 60-741.5(a). These regulations prohibit discrimination against qualified individuals based on their status as protected veterans or individuals with disabilities, and prohibit discrimination against all individuals based on their race, color, religion, sex, sexual orientation, gender identity or national origin. Moreover, these regulations require that covered prime contractors and subcontractors take affirmative action to employ and advance in employment individuals without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
DiaSorin Inc and DiaSorin Molecular LLC are Affirmative Action and Equal Opportunity Employers. 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.
Equal Employment Opportunity
Posters: https://www.dol.gov/agencies/ofccp/posters.
If you’d like to view a copy of the company’s affirmative action plan or policy statement, please email: hrtalent@diasorin.com. If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please e-mail: hrtalent@diasorin.com or call toll-free 1.800.328.1482.