QA Engineer

Sanmina•Pleasant Prairie, WI

About The Position

QA Engineer 3 Sanmina Corporation (Nasdaq: SANM) is a leading integrated manufacturing solutions provider serving the fastest-growing segments of the global Electronics Manufacturing Services (EMS) market. Recognized as a technology leader, Sanmina Corporation provides end-to-end manufacturing solutions, delivering superior quality and support to Original Equipment Manufacturers (OEMs) primarily in the communications networks, defense and aerospace, industrial and semiconductor systems, medical, multimedia, computing and storage, automotive and clean technology sectors. Sanmina Corporation has facilities strategically located in key regions throughout the world . QUALITY ENGINEER Job Purpose: The Quality Engineer provides quality engineering and assurance to ensure products and services are produced to exceed customer requirements and expectations. The Quality Engineer works in conjunction with other business and engineering disciplines using a cross-functional approach to ensure new/improved and current products and processes are in compliance with applicable Quality Management Systems, standards and regulations. Assist the department in the maintenance of ISO 13485. Conduct internal and supplier audits as required. Analyzes reports and returned products and recommends corrective action. Nature of Duties: 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.

Requirements

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.

Nice To Haves

Lean/ Six Sigma implementation experience preferred
ASQ Certification as a Quality Engineer or Six Sigma Green/Black Belt desired.

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
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.