Supplier Quality Engineer

Diasorin•Northbrook, IL

11d•Onsite

About The Position

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.

Requirements

Bachelor's Degree in a technical field
7+ Years related experience and/or training (in lieu of degree)
4+ Years of quality, supplier quality, or manufacturing experience in a relevant industry.
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
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.

Nice To Haves

ASQ Certified Quality Engineer preferred
Relevant combinations of education, experience, certification, and merit may be considered upon the review of immediate report.
or, an advanced degree in a technical field and 2 years relevant work experience/training

Responsibilities

Supporting Instrument, Cassette and Reagent Manufacturing, in addition to, interfacing with Sourcing to develop and maintain the supplier quality improvement program.
Functioning as the 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.
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.