About the Job

Join a rapidly growing and financially successful OEM medical device company in the Boston area. We offer excellent compensation, benefits, bonus opportunity and relocation package.

Responsibilities:

 Provide support to project development teams regarding quality issues and measurement techniques. Review and interpret customer specifications and negotiate requirements. Create purchasing specifications. Use DOE's and FMEA's to develop and improve processes. Conduct statistical studies of process capability and process control. Be involved in validation protocols. All manufacturing is done in a 100K clean room, FDA environment.

Requirements:

 BS Engineering degree plus 5 to 10 years of Quality experience and a minimum of 2 years within a medical device manufacturing facility. Experience with ISO 13485:2003 and ISO 14971 risk management and validation process. ASQ (CQE & CQA) preferred. Knowledge of Lean/Sigmamanufacturing. Plastic part assembly and injection molding knowledge desired. Apply Now!