Dräger is Hiring a Sr Supplier Quality Engineer Near Andover, MA
What Will You Do
Support the introduction of new products concerning all supplier quality, first article inspection approval and related processes; drive and coordinate First Article Inspection activities in Production to ensure efficient part qualification.
Interface with Suppliers, R&D, LCE, Production and Sourcing to drive continuous quality improvements that minimize the Costs of Quality, specifically Failure on Arrival/Install (FOA/FOI) issues, Field Failures, and Factory defects.
Specify and develop incoming inspection acceptance/test procedures relating to products/components. Write FAI quality plan requirements; maintain quality relevant master data in SAP.
Work closely within SP/SQA teams to manage and implement supplier/engineering changes, process controls and quality plans; support New Product Introductions and transfers.
Support identification and resolution of Non-Conforming material via the MRB process; drives resolution of quality issues back to the supplier for rapid resolution, including non-conformances and customer complaints.
Analyze and report on supplier quality metrics and drive improvement measures; Assign, track, and approve Supplier Corrective Action Requests.
Provide direct, daily support to “keep production running” with regard to supplier quality related issues.
Collaborate, train and mentor supplier representatives in best practices in quality systems, process and controls methods, problem solving and statistical tools.
Develop and communicate Draeger Medical expectations for quality performance, continuous improvement, quality systems, process controls infrastructure for high leverage/critical sustaining parts and new products sourced to contract manufacturers.
Assessment of supplier performing R&D tasks.
Negotiate quality assurance agreements with suppliers.
Perform and coordinate supplier surveys and quality system and process control audits to applicable ISO standards
Performs other duties as needed and assigned.
EducationBS engineering or another related technical field. Related Experience
5 to 10 years in manufacturing/engineering/quality engineering experience with a minimum of 5 years in supplier quality; medical device industry experience strongly preferred.
Experience in communicating key product characteristics to suppliers and supporting implementing of quality assurance methods to control key process parameters at suppliers (SPC, Gage R&R, FMEA, Poke-Yoke, etc.)
ASQ CQE, Lean and Six Sigma certification/experience preferred.
Experience and knowledge of SAP Quality Module- ERP system- and Aras strongly preferred.
Special Competencies Or Certifications
Effective problem solving, root-cause analytical skills. Ability to effectively communicate and present information to management and suppliers.
Demonstrated knowledge of Quality Management System tools, Corrective and Preventive Action (CAPA), complaints and risk management, product quality improvement and continuous improvement methodologies.
Willingness to build up in-depth understanding of site level products and related processes.
Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design/process verification and validation, production and process controls.
Proficiency with Microsoft Excel spreadsheet development and analysis.
Willingness and flexibility for business travel both domestically and abroad, when required (25%).