4335BR - Senior Engineer, Quality LOCATION: Wilmington, MA (01887) ---- up to 10% Travel This is a Retained Executive Search, our client is a Major health products organization with the oldest, best known and most respected healthcare brands in the world. We are searching for a Senior Engineer, Quality Assurance to work out of our Wilmington, MA location. If you are interest please forward your resume and I will respond back ASAP. POSITION DETAILS Salary Range: $63k to 78K US Citizen or Permanent Resident [Green Card Holder] only Reports to: Manager of QA Best Industry- Bio-Tech , Medical Device , Pharmaceutical Department : Quality Assurance 4 Year Degree 5-10 years exp Up to 10% Travel NO Relocation Available Responsible for quality engineering duties including developing and defining quality systems, developing and implementing statistical methods to improve manufacturing processes, supporting product development initiatives and coordinating process enhancements through the practical application of quality tools. Additionally, assists manufacturing and engineering personnel in preventative and corrective action (CAPA) investigation. Conduct and support QA/Operations investigation activities to address customer quality events (CQE), internal failures and complaints; reduce process variation; eliminate non-value added activities and assist in the development and implementation of CAPAs. Improve the effectiveness of the Quality System through the application of Lean, DOEs, statistical analysis and Six Sigma tools while ensuring compliance to both internal and external requirements. Develop and apply statistical methods to assess process performance and potential risks and drive continual improvement programs. Prepare and/or review and approve validations, FMEAs, risk analyses, SOPs and manufacturing/inspection procedures ensuring adherence to regulatory, global and internal requirements. Collect and analyze data and prepare reports. Understand and perform all aspects of the corrective action system (CATSWeb) including evaluation of failure investigation and corrective action plans, root cause analysis and follow-up activities. Continuously monitor process capability indices to identify potential risks as well as opportunities for improvement. Develop inspection procedures, methods, sampling plans and specifications in support of the development of new products and process modifications. Participate in internal and external audits including scheduling, auditing, preparation or reports and follow-up activities. Candidate Must Have: BS degree in Engineering. 5 years quality engineering experience required, preferably in a Medical Device industry. Experience and demonstrated application of industrial statistics is required including SPC, Design of Experiments, process capability and sampling techniques. Experience with QSR and ISO 9000 is required. CQE (Certified Quality Engineer) preferred.