Supplier Quality Engineer

diasorinsp•Cypress, CA

37d•$69,000 - $117,000•Onsite

About The Position

Diasorin is a global leader in immunodiagnostic and molecular diagnostic solutions, dedicated to advancing science to improve patient outcomes worldwide. For over 50 years, the company has blended scientific expertise with an entrepreneurial spirit, focusing on innovation, accountability, and results to deliver reliable diagnostic solutions. Diasorin continually invests in research, technology, and its people, guided by values of operational excellence, customer focus, and teamwork. The company fosters an environment where teams can think boldly, act decisively, and turn ideas into significant impacts across a broad range of specialty diagnostic portfolios. Joining Diasorin means contributing to future advancements and building 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, or an advanced degree in a technical field and 2 years relevant work experience/training
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
CMM experience preferred

Responsibilities

Supporting Instrument, Cassette and Reagent Manufacturing, and 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.
Participating or leading in Quality Control processes associated with setting raw material specifications, 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.
Participating in Material Review Board, Supplier Review Board, and Supplier audits.
Monitoring and measuring supplier performance through production line statistics, field data, company inspections, and audits.
Establishing and reporting supplier quality metrics.
Utilizing quality engineering principles and problem-solving skills to develop and optimize supplier performance.
Assisting in the supplier selection and qualification process for new products and sourcing activities.
Assessing supplier production control and quality programs, and identifying shortfalls.
Participating in or leading the coordination of supplier conference meetings, site visits, and audits.
Establishing meetings with low-scoring suppliers to communicate quality issues, discuss root causes, and drive corrective actions.
Performing specification reviews and correlating inspection methods between Luminex and its suppliers.
Acting as the technical liaison between suppliers and manufacturing plants.
Working with critical suppliers to drive development and modification of purchased product’s test methods, test plans, and test fixtures.
Escalating supplier problems and potential issues through management channels.
Driving continuous improvement projects with suppliers.
Assisting with establishing and fulfilling annual CAPP objectives.
Participating in combined department operations as required.
Conducting or participating in applicable departmental and interdepartmental training.
Monitoring procedural and engineering change releases and assessing departmental impact.
Driving departmental document change control, manufacturer change control, and engineering change control activities.
Leading or assisting in specification development for raw materials, products, acceptance, etc.
Participating in product planning and product realization processes.
Participating in the Material Review Board.
Participating in or chairing the Supplier Review Board.
Leading or participating in supplier audits and audit reporting.
Participating in the design and implementation of departmental quality initiatives, programs, and policy.
Driving the resolution of department audit findings, observations, and recommendations.
Leading or assisting in the investigation and resolution of problems initiated through non-conformances, corrective action, or customer complaints.
Performing other duties as assigned.