Quality Engineer

Organization: 
AltheaDx
Job Location: 
San Diego, CA
Job Description: 

AltheaDx performs assay development and clinical testing services for biopharma customers and physicians. Our biopharma service menu covers early stage biomarker discovery through companion diagnostics development, clinical trials and regulatory submission to FDA.

•Support the implementation of quality systems compliant with CLIA, GLP, ISO 13485, 21 CFR 820 (QSR), and States of CA, NY, and FL regulations.
•Work closely with R&D, Manufacturing and Commercial personnel on development, validation and transfer of new products and services.
•Provide verification/validation guidance and support (IQ/OQ/PQ, design, software, etc.). Review and approve protocols and reports and assist with root cause and corrective actions as needed.
•Apply world class techniques (e.g. Six Sigma, ANOVA, Taguchi, SPC, Gauge R&R, etc.) to ensure the development of robust, predictive quality systems which are easily transferable and maintainable in a production environment.
•Lead the risk management process (FMEA, Hazard Analysis, ISO 14971, etc.) throughout the product lifecycle.
•Guide R&D and Operations teams in root cause analysis of CAPAs, deviations, internal/external audit findings, complaints, etc.
•Review and approve change orders, quality system procedures, verification and validation protocols/reports, complaints, quality audits, and other quality records.
•Trend and analyze sources of quality data and prepare metrics for management review.
•Participate in the Material Review Board (MRB) and collaborate with other departments in the identification, segregation, evaluation and disposition of nonconforming material.
•Represent quality in the purchasing, material and supplier controls program. Design incoming material inspection strategies, institute sampling plans, develop procedures for incoming inspection and qualify suppliers as needed.

Requirements: 

•B.S. in engineering or relevant science field. A degree in Biology or Microbiology is a plus. ASQ certifications (CQM, CQA, CQE) are also a plus.
•Minimum of 2 years of quality engineering experience with new product development and manufacturing in the IVD industry. Experience in CLIA laboratories is a plus.
•In depth understanding of GMPs and ISO 13485 and their application to diagnostics. CLIA and GLP experience is a plus.
•Verifiable track record of applying effective quality systems in the areas of development, design transfer, and manufacturing (day-to-day operations).
•Experience with verification & validation (design, process, equipment, software: OTS or developed in-house, etc.) in a leading or support role.
•Solutions oriented with exceptional ability to balance compliance and business requirements. Experience with guiding diverse teams within an organization.
• Excellent communication skills both written and verbal.
•Strong desire to excel as “hands on” contributor within a rapidly growing company.

Contact Information: 

To apply, please visit: http://www.altheadx.com/about/careers/