Supplier Quality Engineer II

Obsessed by Science. Entrepreneurial by Nature. United by Purpose.

Diasorin is a global leader in immunodiagnostic and molecular diagnostic solutions, advancing science to improve patient outcomes worldwide. For more than 50 years, we have combined scientific rigor with an entrepreneurial mindset, operating with a strong commitment to innovation, accountability, and results to deliver trusted diagnostic solutions.

As the Diagnostics Specialist, Diasorin continuously invests in research, technology, and people. Guided by our values of operational excellence, customer focus, and teamwork, we empower teams to think boldly, act decisively, and transform ideas into meaningful impact across one of the industry’s broadest specialty diagnostic portfolios.

When you join Diasorin, you are not just filling a role. You are helping build what comes next.

Why Join Diasorin

• Build What Matters
  Take ownership, challenge the status quo, and contribute directly to solutions that improve patient care worldwide.
• Innovate with Agility at a Global Scale
  Work in an entrepreneurial environment that enables speed, collaboration, and global impact.
• Grow in a People-Centered Culture
  Thrive in a culture that values accountability, inclusion, and continuous development.

Job Scope

Supplier Quality Engineer II position based in Cypress, supporting the molecular diagnostics division
Responsibilities centered entirely on supplier management: qualifying, maintaining, and evaluating suppliers against compliance and regulatory requirements from FDA and EU markets

• Supports Instrument, Cassette and Reagent Manufacturing, in addition to, interfacing with Sourcing to develop and maintain the supplier quality improvement program.
• Handles all supplier-related issues across multiple sites, including Austin, Chicago, and Toronto, despite beingphysically located in Cypress
• Works with raw material suppliers (enzymes, nucleotides, critical ingredients for assays), OEM suppliers(component manufacturers for instruments and kits), and consumable suppliers (plastic and molded parts)
• Functions as Manufacturing interface with Engineering, Sourcing and Quality Assurance for supplier sourcing and supplier performance and participates or leads in Quality Control processes associated with setting appropriate raw material specification, test method development, product development, product sustaining engineering, automated inspection methods (CMM experience preferred), equipment and method validations, document development, and document and engineering change control. Participate in Material Review Board, Supplier Review Board and Supplier audits.
• Frequent interaction with suppliers, intra-department interaction as well as, frequent inter-department interfaces with Purchasing, Quality Assurance, Instrument Manufacturing, Production Planning, Manufacturing Engineering, Research and Development (HW, SW, & Reagent), Cassette Manufacturing, Reagent Manufacturing, Reagent Quality Control and Document Control.

Duties and Responsibilies

• Monitor and Measure supplier performance through measurement of production line statistics, Field data, company inspections, and audits.

• Establish and report supplier quality metrics as required.

• Utilize quality engineering principles and problem solving skills to develop and optimize supplier performance

• Assists in supplier selection & qualification process for new products and sourcing activities. Assess supplier production control and quality programs, identify shortfalls to expectation

• Participate in or lead the coordination of supplier conference meetings, site visits and audits.

• Establish meetings with low scoring suppliers to communicate quality issues, discuss root cause and drive corrective actions.

• Perform spec. reviews and correlate inspection methods between Luminex and its’ suppliers.

• Act as the technical liaison between the suppliers and the manufacturing plants.

• Work with critical suppliers to drive development and modification of purchased product’s test methods, test plans, and test fixtures.

• Escalate Supplier problems and potential issues through management channels as necessary.

• Drive continuous improvement projects with suppliers.

• Assist with establishing annual CAPP objectives; fulfill individual CAPP objectives.
• Participate in combined department operations as required.

• Conduct or participate in applicable departmental and interdepartmental training.

• Monitor procedural and engineering change releases; assess departmental impact.

• Drive departmental document change control, manufacturer change control and engineering change control activities.

• Lead or assist in specification development for raw materials, products, acceptance, etc.

• Participate in product planning and product realization processes.

• Participate in the Material Review Board.

• Participate or chair the Supplier Review Board

• Lead or participate in supplier audits and audit reporting.

• Participate in the design and implementation of departmental quality initiatives, programs, and policy.

• Drive the resolution of department audit findings, observations, and recommendations.

• Lead or assist in the investigation and resolution of problems initiated through non-conformances, corrective action, or customer complaints.

• Other duties as assigned.

Education, Experience and Qualifications

• Bachelor's Degree in a technical field OR 7+ Years related experience and/or training (in lieu of degree)
• 2 to 4+ Years of supplier quality, or manufacturing experience in regulated industry such medical device, biotech, or pharmaceutical industry. or, an advanced degree in a technical field and 2 years relevant work experience
• Must understand ISO 13485 and other applicable regulations
• Understanding of compliance requirements from FDA and EU markets mandatory

Training and Skills

• Proficient in Microsoft Word, Excel, Access and PowerPoint programs.

• Effective oral and written communication skills across all levels (peers, managers, executives)

• Strong statistical and data analysis skills and problem solving techniques; SPC, DOE

• Relevant combinations of education, experience, certification, and merit may be considered upon the review of immediate report.

• Thorough knowledge of FDA regulations and cGMP guidelines.

• Highly organized with proven time management and prioritization skills.

• Ability to work independently and with minimal supervision

• Ability to handle the pressure of meeting tight deadlines

• Fluent in using Microsoft Office suite.

Licenses and Certifications

• ASQ Certified Quality Engineer preferred

Standard Physical Demands

• Standing - Frequently
• Stooping - Frequently
• Bending - Occasionally
• Climbing - Occasionally
• Sitting - Occasionally
• Kneeling - Occasionally
• Lifting of at least 40lbs - Occasionally

Travel Requirements

• 5% to 10% Travel may be required

Visa Sponsorship not available for this role

Company paid relocation not available for this role

The hiring range for this position is $71,000-$117,000 annually. The salary range for this role represents the numerous factors considered in the hiring decisions including, but not limited to, educations, skills, work experience, certifications, etc. Beyond base salary, Diasorin offers a competitive rewards package focused on your overall well-being. We are proud to offer a comprehensive plan of health benefits, retirement and financial wellbeing, time off programs, wellbeing support and perks. Benefits may vary by role, country, region, union status, and other employment status factors. You may also be eligible to participate in an annual incentive program. An incentive award, if any, depends on various factors, including, individual and organizational performance.

Diasorin is committed to building a workplace where people feel empowered to contribute ideas, take ownership, and grow their careers. We believe diverse perspectives strengthen innovation and help us deliver meaningful impact for patients and customers worldwide.

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, disability, protected veteran status, or any other characteristic protected by applicable law.

This posting and recruitment process are subject to applicable local laws and regulations in the country where the position is located. Additional employment disclosures, candidate rights, and employment conditions may apply based on local jurisdiction.

Individuals hired will be required to verify identity and eligibility to work and may be subject to a background check and drug screening where permitted by law. Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities during the application process. If assistance is required, please contact View email address on aiapply.co.

​Recruitment Fraud Notice

Diasorin never requests payment, financial information, or personal banking details from candidates at any stage of the recruitment process. Official communications from Diasorin recruiters will only come from a verified @diasorin.com email address. If you have questions about the legitimacy of a recruitment communication, please contact View email address on aiapply.co for verification.

Unauthorized third-party recruiting agencies may not submit candidates for this position without prior written authorization from the Diasorin Human Resources Department.