Job Description Summary

The primary purpose of this position is to develop the risk-based supplier management process, lead the critical supplier-related projects, and support daily supplier non-conformances and requests for change. This position will also be responsible for performing GMP/ISO audits on suppliers, proposing improvements to their quality system and tracking the closure of any audit related non-conformance.

Essential Duties & Responsibilities:

• 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.

Job Requirements Minimum Education:

• Bachelor’s degree in Engineering.
• Master’s degree strongly preferred.
• Six Sigma Black Belt Certified or Certified Quality Engineer preferred.

Minimum Experience:

7-10 years experience in Quality, Supplier Quality, Supply Chain or related process driven field.

Specialized Knowledge:

• Negotiating, influence and leadership abilities.
• Computer knowledge: MS Excel, MS Word, MS Power Point, Minitab.
• Quality System Audits knowledge.
• Good manufacturing and documentation practices.
• Drawings and blueprints knowledge.
• 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 Region’s product.
• High visual and tactile demand.

Special Skills:

• Measurement and test equipment knowledge.
• Excellent communication (written and verbal) skills with internal and external customers.
• Presentation skills.
• Ability to work in a matrix organization, strong analytical skills. Problem solving and skills.
• Proven leadership, communication, and project management.
• Demonstrated ability to lead team activities. Strong ability to coach.
• Advanced problem solving skills.
• Strong communication, presentation, follow-through, and organizational skills.
• Ability to effectively work with coworkers and all levels of the organization