Supplier Quality Engineer

Biotechnology and Pharmaceutical Supplier Quality Engineer Job Description:Primary Function Responsible for evaluating and monitoring suppliers to ensure regulatory compliance as well as meeting organizational supplier performance goals. Lead Supplier Quality and Process Assessments, help drive systemic improvements and support site initiatives. Duty / Responsibility Performing lead auditor function in the execution, management and closure of Quality Management System issues and perform Process audits (via travel) on suppliers that provide components assemblies and services or Finished Goods. Support all supplier related activities such as performance monitoring, creation and closure of supplier corrective actions (SCAR) and high level corrective action requests (CAPA), Maintain Database(s) that ensures all first article and qualification requirements have been met prior to material being released for production. Follow up on observations and recommendations with suppliers to resolve quality issues. May represent the Supplier Quality function in Material Review Board and insure any supplier corrective actions have been implemented and verified for affectively. Participate and/or lead quality aspects of team initiatives to improve value and overall performance of our suppliers. Special Knowledge / Skill Working knowledge of SPC, FMEA, and other quality improvement techniques is required Must be knowledgeable of cGMP and relevant requirements Must have good knowledge of MS office tools to include excel and access Should be familiar with closed loop ERP systems. Experience Requires 2+ years experience in Quality Assurance with emphasis on Supplier Quality. Requires eperience with PCB manufacturing or electronic components for design. Working knowledge in manufacturing of medical devices and regulatory requirements is preferred Experience in mechanical (including machining) components and assemblies preferred. RoHS experience preferred.Education / Training Requires a BS degree in Electrical Engineering. ASQ Certification preferred. Certificate in ISO 9001/ 2000 Lead Auditor preferred. MS preferred.Job Experience:• Requires eperience with PCB manufacturing or electronic components for design.Minimum Education Required: BachelorYears of Experience Required: At Least 3 YearsExpected Travel Time: NoneThis company may offer relocation assistance. Please visit us online at www.bostonscientific.com for more information.