Supplier Quality Engineer
Contract to Hire position!
- Improve supplier quality performance for assigned suppliers.
- Manage supplier audit program and overall supplier approval/rating program through robust qualification processes.
- Assure supplier compliance to Lake Region Medical QMS and regulatory requirements through supplier monitoring process.
- Manage the supplier process change process.
- Develop positive relationships and work closely with Engineering and Supply Chain to manage and implement supplier/engineering changes, New Product Introductions, and transfers.
- Interface with Suppliers, Engineering, Operations and Supply Chain to drive Quality improvements that minimize the Costs of Quality, specifically Incoming Rejects, Failures, and operational defects.
- Work with product support teams on component quality issues and supplier initiatives.
- Work directly with vendors under the control of the Lake Region Medical QMS. This involves travel to supplier sites so this person must be available to travel at short notice.
- Support implementation of initiatives such as Supplied Data and Dock to Stock.
- Assure Corrective and Preventive Action plans are developed and executed at assigned suppliers in compliance with the CAPA process.
- Develop and support Supplier Quality Engineering program.
- Review document and procedure changes for quality requirements and compliance with the quality system.
- Provide quality support for the disposition of material.
- Support the implementation of continuous improvement initiatives for productive processes.
- Comply with all work rules including those pertaining to safety, health, and quality.
- Provide leadership and guidance to QC Technicians who perform receiving inspection activities.
- BS degree in engineering or related discipline.
- Minimum 5 yearsâ€™ experience in medical device manufacturing, 3 years in quality assurance
- Strong experience with ISO 13485,QSR, and/or ISO9001 systems
- ASQ certified quality engineer/manager desired
- ASQ or equivalent auditor certification desired
- Must have the ability to interact professionally, with associates at all levels of the organization.
- Keyboarding required for inputting and analyzing data, memorandums and reports.
- Self-started with the ability to facilitate activities with little direction
- Deadline sensitive with a high degree of concentration.
- Attention to details.
- Must be able to work with diverse groups within the company.
- Must be able to think critically about technical matters that may impact upon the fit, form or function of Lake Regionâ€™s product.
- High visual and tactile demand.