Senior Supplier Quality Engineer/Quality Manager Resume Example

Monitored and reported trends in supplier, manufacturing, and customer non-conformances to responsible departments.  Managed supply chain performance metrics and monitoring. Met with OEM suppliers either on-site or through webinars to assess quality, delivery, SCARs, or new product development. ESD Coordinator for entire facility, and Calibration manager for 4 years.

• Met monthly with Procurement, Quality, and Supply Chain leads to review Supplier performance metrics. Results:  Disapproved chronically poor performing suppliers, began process for finding a second source for sole suppliers, and visited sites/webinars to improve vendor's delivery, quality, or offer  technical assistance.      
• Designed and implemented Failure Analysis/FRACAS process for non-conforming materials both from OEM suppliers and customer returns. Results: First pass production yield improved by over 25%.
• Reduced customer corrective actions from twice per month to three per year. Worked closely with senior SQE to evaluate non-conforming product that escaped from supplier's facility.          
• Established Supply Chain Manual on web portal to standardize SRCTec requirements for nearly 200 vendors. Results: Reduced supplier non-conformances 30% each year for four consecutive years.      
• Calibration coordinator role assigned six weeks before initial ISO 9001 audit in 2008.  Results: ISO audit passed without any non-conformances or OFIs for calibration.             
• Promoted to ESD Coordinator in 2009.  Results: Compliant to industry standard ESD S20.20 2007 in less than six months, and increased tested reliability of product by more than 50% over two years.       
• Implemented Lean Manufacturing principles. Results: 11 week cycle time reduced to less than 2 weeks. Cost savings estimated to be more than $74,000 for the first six months, with improved on-time delivery metrics.      
• Initiated in-house equipment calibration for mechanical items, rather than outsourcing. Results: Saved nearly $20,000 annually for total calibration budget of $175,000      
  

Processed vectored biotechnology culture from cryogenics to protein harvest to be used as an injectable drug.  Consistently followed strict FDA standards and protocols.

• Performed testing and data review of raw material samples and in-process, batch release, and stability samples of bulk drug substance in a cGMP compliant environment        
• Executed process steps for required Material Batch Records (MBR) which included: autoclaving of equipment, clean and steam bioreactors and transfer lines, verify and validate instrumentation, corrections to executed MBRs, SOPs and log sheets as required by FDA procedure.       
  
• Verified through control charts progression of cell cultures for Ph levels, temperature, potential contamination, peak population and feed injection points.  Documented every step and calculation on MBR through “done by/checked by” procedure

Interfaced with customers and suppliers concerning quality issues, production delays, or product improvements. Supervised 15 employees on shift and made production decisions based on COPQ (cost of poor quality), production timelines, and equipment shutdown costs. 

• Statistical process control chart implementation and monitoring for extrusion and aqueous coating operations
• CAT member for preventative/corrective action implementation
  
• QA representative in daily staff meetings with production and management to determine final disposition of non-conforming product.        
• Established criteria for QC to perform in-process inspections or destructive testing to validate manufacturing based on customer returns or complaints
  
• Determined disposition of finished product and judged product acceptability in comparison to specifications     
• Conducted visual inspections and physical tests to determine conformance
• ISO Quality auditor that assisted in one of the first US facilities to obtain ISO 9001 certification.        
• Wrote or rewrote quality assurance procedures to reflect new or modified process to ensure a consistent, high degree of accuracy.