An amazing opportunity to join our DiaSorin Molecular LLC as our Quality Systems Manager located in our Cypress, CA USA office location. At DiaSorin Molecular, we maintain our industry reputation as a market leader committed to providing products that accommodate the laboratory’s needs through reliable products, quality manufacturing practices and flexible solutions. Our product lines include the Simplexa™ molecular chemistries run on the Integrated Cycler. We strive to be the first company to provide diagnostic solutions for emerging infectious diseases, with past accomplishments including assays for West Nile Virus, SARS, and Influenza A H1N1 (2009).
To ensure compliance to FDA ISO, and various regulatory requirements through management of Document Control, Product Release, Internal audits, and CAPA systems.
Ensure the facility is in compliance to ISO13485, IVDD, CMDCAS, and QSR requirements.
Provides a leadership role in the effort to promote continuous improvement of Quality System processes.
Develops, monitor and meet, department and individual goals & objectives.
Creating a sense of urgency and helping team to deliver projects and activities to agreed upon deadlines.
Manage the manpower, equipment and resources for effective operations.
Oversee the internal quality audit system.
Oversee the CAPA system as it relates to universal issues.
Oversee the document control system.
Oversees the training system
Oversee the product release process
Generate key performance indicators and Support Management Review process.
Follow corporate policies and procedures.
Participates/supports in the audits of third party audits.
Assists in creating annual budget based on project needs.
EDUCATION: College Degree with B.S. preferred.
EXPERIENCE: Requires 4 or more years working experience in the healthcare industry.
Requires supervisory experience. Other relevant experience may be considered.
ASQ Certified Auditor a plus.
Working knowledge of Industry related Quality Systems, Medical Device QSRs, familiarity with International Quality Standards.
Additional Salary Information: As per local and Company requirements for DiaSorin Molecular LLC.
DiaSorin Molecular LLC offers a competitive compensation package includes Medical, Dental, Employer Life insurance, STD and LTD insurance, 6% match of 401k plan or Roth 401k plan with vesting schedule.
DiaSorin Molecular is dedicated to infectious disease diagnostic testing services, products, and information. We are focused on diagnostic solutions that can help improve the health of patients and populations that can help improve the world. Our company has continued to create a culture of innovation, quality, and personalized service, and we enjoy a reputation as a resource for infectious dise...ase understanding that goes beyond the test.
DiaSorin Molecular offers products used by hospitals, commercial laboratories, physicians and public health agencies to assist with the diagnosis, treatment and management of infectious diseases.