T/B S III-Engineering-General Engineering
Supplier Quality Engineer
Incumbent will be responsible to lead and support tasks and projects in the Incoming Inspection area and the supplier quality program. Responsible to lead the overall supplier quality strategy in compliance with Medical Products Division standards. Assist suppliers to improve quality by means of plant assessments and preventive monitoring to drive their process toward certification status. In order to perform effectively incumbent must be knowledgeable of all processes, products, specifications, quality and purchasing functions.
1. Approval of new parts, supplier of raw material and services assuring full compliance with Corporate Division, FDA and other applicable regulations.
2. Works closely with suppliers and buyers as appropriate in the resolution of supplier quality concerns. Initiate and follow up SCAR’s and ICAR’s.
3. Assist the Quality Superintendent in the evaluation and decisions toward the acceptability or rejections of product.
4. Provide support to product/process transfer projects to assure compliance with procedures, as well as facilitation of activities required in the transfer.
5. Develop and support continuous improvement activities to enhance the Quality Systems, using a variety of Quality and Continuous Process Improvement tools; including but not limited to Six Sigma, Kaizen lean methods, etc.
- Assure monthly quality indicators and quarterly Quality Systems Management trends reviews are in order to identify areas for opportunities, both for productivity and quality improvements, supporting our facility quality improvements processes.
7. Work with Improvement Projects for the Supplier Quality System.
8. Maintain direct and continuous communication with incoming inspection operations regarding raw material related issues.
9. Lead supplier’s performance evaluations, along with Incoming and Purchasing Area.
10. Maintain fluid conversation with suppliers in order to correct opportunities found and to improve alignment of requirements and expectations in order to minimize financial impact due to lack of raw material and regulatory.
11. Analyze and Lead raw material to be included in Certification Program and Lot Monitoring.
12. Received Maintenance request records and perform them into the POM’s Program.
- Lead Internal Audits.
14. Lead special projects on related duties.
15. Learn and practice basic ergonomic principles to reduce job-related discomfort and injuries.
16. Observes all company and regulatory EHS requirements.