Our client is a global manufacturer of medical devices with special emphasis on electro-mechanical and cardiovascular products.
The Supplier Quality Engineer (SQE) works as an integral participant of the global Quality Assurance and Supply Chain Management organization directly responsible for managing Company supplier programs. Additionally; the SQE is involved with the Supplier selection process. The SQE acts as the quality liaison between the Company and its suppliers, providing guidance on product and component quality requirements; generating accurate and timely supplier quality data, trends, metrics and related reports; and determining and monitoring the effectiveness of corrective and preventive actions to resolve non-conforming issues.
- Full Time Permanent Position
- Relocation Assistance Available
- Minimum Experience; 3 years in similar type of work
KEY OBJECTIVES and DELIVERABLES:
- Maintain and follow proper compliance and quality systems requirements.
- Conduct first article inspections on new builds or changes to product to ensure the supplier's processes match their capabilities to provide product that meets or exceeds Company specifications.
- Write reports outlining assessment, audit and first article findings, along with recommendations, so that other functions within the Company may make appropriate decisions on selection.
- When necessary, act as project leader (or assist in) for factory transfer projects so that all requirements and specifications are clearly communicated to the supplier.
- Supplier Selection and Assessment.
- Gather and review all documents required for the selection process in a timely and accurate manner.
- Communicate to the potential supplier the selection requirements so that the process is fully understood by the supplier.
- Conduct audits at suppliers' sites, covering quality system registration conformity and production line capability so that a proper and full recommendation/approval can be made on their ability to produce and deliver Quality product.
- Manage and review monthly quality data for yields, trending and process controls. Communicate to the supplier all results and provide feedback to Quality Engineers of data results so that the ongoing performance of the supplier can be measured.
- Request Supplier Corrective Action plan from supplier, based on negative-trending issues from monthly quality data reports. This will include working jointly with the supplier for improvement, resolution and the verification of effectiveness of corrective actions undertaken.
- Act as liaison between supplier and Quality Engineers and Customer Service when the Company issues Corrective Actions due to rejected goods at Incoming Inspection or Manufacturing or from Customer complaints, so that improvements and corrective actions can be implemented and monitored.
- When necessary, Quality incident resolution may require immediate site visits to a supplier's facility to understand the particular issue more and to provide timely feedback to other Company team members.
- Execute, jointly with supplier, continuous improvement programs such as SPC, DOE, PFMEA, Gage R&R, and Control Plans.
- Perform on-going audits of suppliers' production lines to ensure conformity to Company requirements.
- As part of the overall product qualification process, validate product performance to ensure it meets published specification and performance criteria.
- Attend regularly scheduled conference calls with Company management to ensure consistency of supplier status and problem resolution.
- May attend periodic Supplier Performance Reviews.
- May represent the Quality organization on cross-functional teams.
MINIMUM CANDIDATE REQUIREMENTS:
- Requires 4-year degree, preferably in Engineering, Quality or related technical field.
- Must have a minimum of three years experience with supplier assessment, selection and management in high-tech industry as an Engineer in Quality, Engineering or Manufacturing, including experience auditing supplier sites to International Quality System standards.
- Knowledge of ISO 9000 and related quality system requirements (i.e. ISO 13485).
- Demonstrated success in ability to apply audit knowledge and conduct supplier audits.
- Process control knowledge and implementation experience (SPC, Cpk, Gage R & R, DOE, Control Plans, etc.).
- Knowledge of and experience in problem solving implementation.
ADDITIONAL SKILLS & EXPERIENCE PREFERENCES:
- Knowledge of RoHS and WEEE requirements beneficial.
- Knowledge of ESD requirements preferred. Product technical knowledge preferred.
- Proficiency in MS Office and e-mail. Demonstrated ability to make independent, informed decisions.
- Ability to communicate clearly in both written and verbal forms.