Quality Systems Associate

at DiaSorin Inc. in Stillwater, Minnesota, United States

Job Description

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:
*Participating in the design, creation, and implementation and monitoring of programs and methodologies to ensure that Luminex products meet established specifications, design criteria, quality standards and customer requirements.
*Sharing responsibility for Quality Assurance operations associated with Luminex products and processes.
*Thorough knowledge of the Luminex Quality Management System is essential to competently fulfill the duties of the position.

Key Responsibilities and Duties
Review and approve manufacturing records (includes all manufacturing department BPRs) and QC Records (department tests and inspections)
Review and approve Device History Records
Release products for distribution.
Review Product Lot Request records
Review and approve pilot lots
Participate in performing CAPA effectiveness checks, CAPA follow-up and ANR follow-up
Review and approve ECOs and DCOs as assigned
Log, file, maintain and archive various QA records
Prepare materials for QA meetings and, as assigned, present materials at QA meetings.
Coordinate resolution of quality issues with internal personnel and departments
Participate in audits and inspections
Support and participate in other QA related activities as required.
Other duties as assigned.
QUALIFICATIONS
Bachelor's degree in a life science or engineering or equivalent related experience
1+ years Experience in Quality Assurance activities
Experience with participating in formal audits
Experience in Medical Device Manufacturing environment
Knowledge of cGMP regulations (21 CFR 820, CMDR and ISO 13485)
Detail oriented
Competency in use of Microsoft Excel, Word and Outlook
Excellent interpersonal, communication and organizational skills.

What we offer:
Receive a competitive salary and... For full info follow application link.

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.