Supply Quality Engineer Molecular Diagnostics

Job Scope

Supplier Quality Engineer II position based in Cypress, California 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 being physically 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.

Duties and Responsibilities

• 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.
• Assist 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.
• 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 the Material Review Board and participate or chair the Supplier Review Board.
• Lead or participate in supplier audits and audit reporting.
• 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.

Education, Experience and Qualifications

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

Training and Skills

• Thorough knowledge of FDA regulations and cGMP guidelines related to Quality
• Effective oral and written communication skills across all levels (peers, managers, executives)
• Strong statistical and data analysis skills and problem solving techniques; SPC, DOE
• 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.