This position is responsible for ensuring outsourced material, components, services and finished devices meet requirements by applying Quality Assurance principles and tools to supply chain activities, managing supplier relationships from a technical QA perspective, and executing improvement activities such as supplier development, PPAP, Supplier Certification and other CI projects. This position works with internal stakeholders (GSQ Program Manager, Global Procurement, R&D/Engineering, Site Purchasing, Site Operations and Site Quality) to support material flow to manufacturing and maximize value-added contributions and internal customer satisfaction, regulatory compliance and patient safety. This position works with external stakeholders (Customers, Suppliers, Notified Body and Regulatory Bodies) to maximize external customer satisfaction, regulatory compliance, and patient safety.
Essential Duties & Responsibilities
• Responsible for developing strategies for supplier quality programs and initiatives, including leading risk identification and mitigations efforts, supporting the Supplier Quality Management System, and driving improvement through supplier development activities, PPAP and Suppler Certification.
• Identify, execute and maintain initiatives, in conjunction with GSQ, to improve the performance of the supply base. Own the reporting of supplier performance (e.g. Score Cards).
• Manage relationships with internal and external stakeholders as a partnership. Work collaboratively with Procurement and Operations partners to improve processes that drive supplier performance and reduce supplier-related waste in operations and manufacturing.
• Employ disciplined problem solving methodology to resolve SCARs, identify trends to reduce supplier nonconformances and uncover opportunities for continuous improvement.
• Maintain regulatory compliance and adherence to Purchasing Control Procedures for the location assigned.
• Work on special projects as they arise
Knowledge, Skills & Qualifications
• Ability to think strategically and tactically.
• Relationship management skills
• Thorough knowledge of contemporary Quality Engineering practices such as PPAP, SPC, Root Cause and Fault Tree Analysis
• Knowledge of disciplined problem solving methodologies (Six Sigma, Shainin Red X, etc.) Knowledge of Lean Manufacturing Practices
• Knowledge of Project Management Principles
Education and Experience
• Bachelor’s degree in a technical field, from an accredited college or university is preferred
• ASQ or equivalent Professional Certification highly desired: e.g. CQE, CSSGB, CSSBB, and CSQP. CQA/Exemplar Global certification also desirable
• Minimum of 5 years of experience as an engineer and 3 years in medical device manufacturing is required.
• Project management and manufacturing experience. Manufacturing Process knowledge desired.
• Must be at least 18 years of age
• Must pass pre-employment drug screen and background check
Travel Requirements (only select one of the below options)
• Typically requires travel 5-20% of the time
Physical Requirements and Work Environment (Office position – may need to be edited depending on the position)
• This is largely a sedentary role.
• This job operates in a professional office environment and routinely uses standard office equipment.
We are an Equal Employment Opportunity Employer, Female/Minority/Veterans/Disabled/Sexual Orientation/Gender Identity.
ICU Medical, Inc. encourages individuals with disabilities to apply for positions of interest. If you need accommodations to complete the application process, please contact Human Resources at 949-366.3578.