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SANMINA-SCI TECHNOLOGY INDIA PRIVATE LIMITED · 16 hours ago

QA Engineer

Pleasant Prairie, WI

Full-time

Onsite

Senior Level

5+ years exp

Sanmina Corporation is a leading integrated manufacturing solutions provider in the global Electronics Manufacturing Services market. The Quality Engineer role focuses on ensuring products and services meet customer requirements through quality engineering and assurance, involving collaboration with various business and engineering disciplines.

Responsibilities

Lead quality planning activities for new product release projects, including verification and validation plans

Contributes to validation planning for new and existing processes

Initiate or assist in cost reductions of product inspections

Ensure effective product engineering control and transfer to production

Provide validation, sampling, and statistical analysis support to other functions in the organization

Works under indirect supervision following established practices and clear-cut policies in the performance of majority of duties

Provide assistance with maintenance of an ISO 13485 compliant system

Provide day-to-day quality engineering support for specific customer programs

Interface closely with operations, manufacturing and test engineering, along with program management, in all aspects of the customer program

Responsibility, Authority and Accountability for customer Product and Process Quality including continual quality improvement, risk analysis and reduction, as well as corrective and preventive action responses

Customer interface for all regular Quality Engineering level communication

Utilize Six Sigma methodologies for process improvement

Qualification

ISO 13485Quality EngineeringSix SigmaFMEAStatistical AnalysisLean ImplementationProblem SolvingCommunication SkillsOrganizational Skills

Required

Bachelor's Degree in Electrical, Electronic, Industrial Engineering or similar

5+ years Quality Engineering experience in a manufacturing environment, preferably in the medical device industry

Experience with and solid knowledge of ISO 13485 and one or more of the following quality management systems (ISO 9001, TL9000)

Solid experience with medical core tools i.e PFMEA, Control Plans, SPC, MSA

Experience with validation processes (components, process and design)

Able to define and/or interpret problems, collect data, establish facts and draw valid conclusions

Effectively communicate with co-workers, customers, and suppliers

Interpret an extensive variety of industry standards, technical instructions, drawings, and specifications

Have a thorough understanding of problem-solving and quality improvement tools and techniques

This includes knowledge of management and planning tools, quality tools, preventive and corrective actions, and how to overcome barriers to quality improvements

Problem solving using root cause methodologies

Applying statistics and software in data analysis

Application of failure modes and effects analysis (FMEA)

Excellent organizational and communication skills

Flexibility for handling a wide range of activities

Ability to work under pressure, multi-task, and prioritize tasks with strict deadlines

Teaches others new processes and procedures