QA Associate

DiaSorin; Toronto; On-site; CAD 77,000 - 90,000; Full time

Job summary

A global leader in diagnostic solutions is seeking a Quality Assurance professional in Toronto, Ontario. The role involves ensuring Luminex products meet quality standards and regulatory requirements. Candidates should possess an associate degree and have over three years of experience in Quality Assurance, including audit participation. A competitive salary range of $56,000 to $65,000 is offered, along with a benefits package that supports career growth.

Benefits

Competitive wages and benefits package

Supportive, collaborative environment

Qualifications

• 3+ years of experience in Quality Assurance activities.
• 1+ year experience participating in formal audits.
• 1+ year experience in a Medical Device Manufacturing environment.
• 1+ year knowledge of cGMP regulations (21 CFR 820, CMDR and ISO 13485).

Responsibilities

• Review and approve manufacturing records and QC Records.
• Release products for distribution.
• Participate in performing CAPA effectiveness checks.
• Coordinate resolution of quality issues with internal personnel.
• Participate in audits and inspections.

Skills

Detail oriented

Competency in Microsoft Excel

Excellent interpersonal skills

Communication skills

Organizational skills

Education

Associate degree in a life science or engineering

Tools

Microsoft Excel

Microsoft Word

Microsoft Outlook

Job description

Diasorin is a global leader in diagnostic solutions committed to improving healthcare worldwide. This description outlines the responsibilities, qualifications, and benefits for the role.

Overview

Diasorin is a global leader in diagnostic solutions with a legacy of over 50 years. We develop innovative diagnostic assays and instruments trusted by healthcare providers around the world. We offer a broad range of diagnostic tests and Licensed Technology solutions, positioning us as the “Diagnostics Specialist.”

Why Join Diasorin?

• Impactful Work: Your contributions will directly impact patient care and improve lives.
• Global Reach & Innovation: Collaborate with colleagues worldwide and contribute to global healthcare solutions.
• Diverse and Inclusive Culture: We value diversity and provide a supportive, collaborative environment.

Join Our Team: We are looking for passionate and talented individuals ready to embrace new challenges and drive healthcare solutions forward. Apply today and be part of our journey toward a healthier, more connected world.

Job Summary

• This role will participate in the design, creation, implementation and monitoring of programs and methodologies to ensure that Luminex products meet established specifications, design criteria, quality standards and customer requirements.
• This person will share responsibility for Quality Assurance operations associated with Luminex products and processes.
• A thorough knowledge of the Luminex Quality Management System is essential to competently fulfill the duties of the position.

Key Responsibilities & Duties

• Review and approve manufacturing records (including 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

Education, Experience and Qualifications

• Associate degree in a life science or engineering or equivalent related experience required
• 3+ years of experience in Quality Assurance activities
• 1+ year experience participating in formal audits
• 1+ year experience in aMedical Device Manufacturing environment
• 1+ year 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
• Travel up to 10% may be required

What We Offer

Receive a competitive wages 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.

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, protected veteran status, or 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.

Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance during the application process, please contact the North America Talent Acquisition Team at 1-800-328-1482 to request an accommodation. Email: [e-mail]

The salary range is $56,000 to $65,000 dependent on education and work experience.

AI tools are not utilized to screen applicants.

Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations. Offers of employment may be contingent upon successful completion of a pre-employment background check and drug screen. This position is not eligible for partnership with a third-party search firm without expressed, written consent from the Diasorin Human Resources Department.