Supplier Quality Engineer

About the role

Diasorin is a global leader in immunodiagnostic and molecular diagnostic solutions. As the Diagnostics Specialist, you will function as the Manufacturing interface with Engineering, Sourcing and Quality Assurance for supplier sourcing and supplier performance. You will participate or lead in Quality Control processes such as setting appropriate 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.

Responsibilities

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

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
• 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.
• ASQ Certified Quality Engineer preferred

Qualifications

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

Benefits

The hiring range for this position is $69,000-$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.

Pay

The hiring range for this position is $69,000-$117,000 annually.

Schedule

Full-time position.