Supplier Quality Assurance Engineer 3

Sr Supplier Quality Engineer

Responsibilities:

Develop and maintain relationships with suppliers based on honesty and integrity through open channels of communication. Complaint System:

• To ensure that specifications and any other kind of information or technical assistance are available to suppliers to enable them to provide high quality products. Ability to perform identification and analysis of problems, root cause investigation, corrective and preventive actions.
• Ensures compliance with all state and Federal regulations and requirements.
• Suppliers classification, evaluation of compliance of requirements for determination of status of approval, maintenance of authorized supplier list according to applicable SOPs..
• Support on Investigations root cause solutions for product release through nonconformance reports (NC), corrective and preventative actions (CAPA), and material containment.
• Utilizes basic statistical techniques, Experimental Design (DOE), Analytical Risk Management, Hazard Analysis, Control Plans, and Failure Modes and Effects Analysis (FMEA). Conducts and interprets Gage Reproducibility and Repeatability (R&R) studies.
• Provide assistance to junior level staff with more complex tasks that require a higher level of understanding of functions.
• May escalate issues to supervisor/manager for resolution, as deemed necessary.
• May manage and execute testing and release procedures for finished products.
• Ensure effective and efficient use of Quality Engineering techniques such as risk analysis, test method development, statistical data analysis, statistical process control, and the development of sample plans.
• Participate and Lead in supplier Review Board (SRB) review of nonconforming product; recommend disposition and corrective action.
• Develop, apply, revise, and maintain quality standards for processing raw materials and/or reliability of products and/or components into partially finished and/or finished products.
• Perform supplier quality systems and process audits.
• Participate in complex Change Control / Design Control projects
• Generates, reviews and revises procedures, SOPs, drawings, equipment specifications, Engineering Test Reports (ETR) and technical reports.
• Coordinate and manage supplier audits. Responsible for developing and maintaining the supplier quality audit process. Including supplier certification programs.
• To provide support and responses to the observations resulting from internal audits and corrective actions. The response time will be tethered to the annual work performance revision of the person.
• Participation in detection and implementation of opportunities for continuous improvement in operations or development of activities in department.
• Responsible for maintaining and documenting the SRB monthly meetings, in accordance with the requirements of the supplier management procedure.
• Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws, and regulations.
• Employees must be trained according to the curriculum assigned by the training department and kept updated in process and documentation changes.

Qualifications:

• Bachelor's Degree required, preferably in Mechanical, Electrical, Electromechanical, or Biomedical Engineering. Advanced Degree desirable.
• Minimum 5-8 years of related experience; or a Master's degree with 3 years' experience in supplier quality or Quality sistems (Medical devices preferred).
• U.S.A. Visa Required.
• Bilingual (English/Spanish)
• Excellent interpersonal, verbal, and written communication skills in English and Spanish.
• Must have strong technical and analytical skills.
• Good understanding of software management Tools, spreadsheets, and word processing software.
• Problem solving and Root Cause Analysis.
• Experience with Correlation and regression Analysis, Experimental Design (DOE), and acceptance sampling; as well as conducting and interpreting gage R&R studies.
• Good working knowledge of production processes, SOPs, drawings, machine specifications, and required test equipment/fixtures.
• Minitab, Microsoft (Excel, Word, etc).