Supplier Quality Engineer Consultant
Posted on Jun 20, 2019 by Software Specialists
Job title: Supplier Quality Engineer Consultant (4 Openings)
Duration: 6 months+ (Possible extension or full time opportunity) on W2
Location: Fitchburg, WI 53711
- HM need an appropriate ISO 13485 certification candidate.
- Certification in Quality Auditing is mandatory!
- Medical Device Experience desired
- Auditing skill sets and Lead auditor training desired
- Experience in Software Product Development business optional
- Required: SAP
- Preferred: ERP: Agile or PTC Windchill, SEAT-eGRC, Trackwise
- Interacts with peer groups and with suppliers, demonstrates ability to gain cooperation of others, conduct presentations of technical information concerning product development supplier related deliverables or schedules. Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Exercises judgement within defined procedures and practices to determine appropriate action. May need to use good judgement in selecting methods and techniques for obtaining solutions. builds productive internal/external working relationships. Able to work independently with general instruction, detailed instructions will be given for new or special assignments.
- Responsible for Supplier Quality Performance Monitoring, assisting in the development of Quality processes relating to Supplier Quality Control's, works with the team to assist in supplier audits and supplier qualification, assessing supplier capabilities, supplier quality controls, adherence to design outputs, audit and inspection experience, experience with supplier control and design controls, and design ties to supplier, Knowledge or experience with CPK, APQP, Process Capability Statistics in relation to Six Sigma which is essentially process optimization, understands QSIT, serve as a Quality interface to suppliers supporting quality and productivity goals, proactively monitoring and measuring product/process quality and performance trends, and troubleshooting of production/release issues.
- Develop and oversee equipment qualification and process validation plans and lead continuous improvement projects based on process/product trends, customer complaints, industry standards and government regulations.
- Assure quality systems of OEMs, manufacturers and suppliers are maintained and acceptance criteria are in alignment with component/product use and customer expectations.
- Provide Quality oversight of product/process change requests from suppliers, ensuring appropriate regulatory review and adequate validation to support requested changes. Serve as internal and supplier quality auditor, managing planning, execution, reporting and closure of audits and audit findings
- Minimum 8 years professional experience in the applicable role.
- Bachelor's/Master's degree in Engineering. Demonstrated capability and experience in role.