Job Number: 9256
ESSENTIAL DUTIES AND RESPONSIBILITIES
Manage supplier performance and raise potential issues to supplier quality management.
Support supplier risk assessments and updating the Approved Supplier List.
Act as lead auditor for supplier quality audits according to the established supplier audit schedule.
Communicate with suppliers for change notifications and timely follow up actions both internally and externally.
Support the dispositioning of nonconforming material from suppliers occurs in a timely manner and analyze defect trends, in order to initiate appropriate supplier corrective action.
Assist suppliers with conducting FMEA, process capability studies and DOE.
Perform Quality Systems and Process Audits of current and prospective suppliers, including reporting, follow-up and closure of nonconformances.
Recommend opportunities for cost reduction and quality improvements with suppliers.
Support Supplier Quality Engineer III to develop and implement improvements to supplier quality policies, processes and procedures.
Collaborates cross functionally to ensure accurate component specifications are created and implemented as needed.
Coordinate the approval of new suppliers and communication of status to pending suppliers.
- Support developing and implementing methods and procedures for inspecting, testing and evaluating the precision, reliability and accuracy of supplier products and processes.
- Coordinate with customers and suppliers relating to quality performance, trends and corrective actions.
- Work with suppliers to continuously improve products and processes through lean manufacturing and six-sigma principles and techniques to assure the quality of goods and services provided.
- Support the APQP process in design and process reviews.
- Manage qualification of supplier process change requests inclusive of defining customer requirements as necessary.
- Assess supplier process capability for new components, processes, assemblies and/or purchased finished goods.
EDUCATION AND EXPERIENCE
Bachelor s degree in Engineering or a related field is required.
4-7+ years of quality experience in a manufacturing environment or equivalent combination of education and experience is required.
Minimum 4 years of experience in a Supplier Quality role
Experience reading and interpreting blueprints and gage design knowledge is required.
Experience with Lean and Six Sigma methodologies preferred.
Direct experience leading supplier quality investigations and CAPA activities is required.
Professional auditing certification by ISO, ASQ or similar preferred.
In depth knowledge of 21 CFR 820 and ISO 13485 required.
Strong verbal and written communication skills with all organizational levels as well as excellent interpersonal skills are required.
Must have exceptional organizational skills, ability to meet deadlines, thrive in a fast-paced environment and be able to problem solve effectively.