Sr Supplier Quality Engineer

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.

Education :

BS 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.)
• Contract Manufacturing, Electronics, PCBA background.
• International experience preferred.
• 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%).

Draeger has several sites located across North America as well as field-based sales and service positions. Our North America headquarters is located in Telford, PA just north of Philadelphia.

We also have US sites in Andover, MA, and Houston, TX. Our Canada site is located in Mississauga, Ontario.

The design, development and manufacturing of Draeger’s Patient Monitoring product line takes place in our Andover, Massachusetts location.

EEO is the Law

Draeger is an Equal Opportunity Employer. To learn more :

From hospitals to fire departments to industrial customers, people around the world rely on our products : cutting-edge technology that combines real engineering with the digital future.

With over years of experience, passion and the bold ideas of more than 16, employees, we are committed to turning technology into technology for life .