Sr. Quality Engineer - (86058) - Sanmina

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:

With assistance from senior Quality Management, implement and maintain a Quality Management System compliant with ISO 13485:2016.  Assist the department in the implementation of ISO 13485:2016.  Conduct internal and supplier audits as required.  Develops, applies, revises and maintains quality standards for processing materials into partially finished or finished products. Designs and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and/or production equipment. Analyzes reports and returned products and recommends corrective action. Prepares documentation for inspection/testing procedures. 
 
Nature of Duties/Responsibilities:

The primary responsibilities of this position include, but may not be limited to, the following: 

• Provide oversight of the implementation/maintenance of an ISO 13485:2016/QRS 21CFR part 820 compliant system.
• Assist in the maintenance of an AS9100/ISO 9001compliant quality 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 improvements.
• Leads the MRB team to complete all related tasks

Education and Experience:

• 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 and knowledge of ISO 13485:2016 and one or more of the following quality management systems ( AS9100, ISO 9001)
• Solid experience with medical core tools i.e. PFMEA, Control Plans, SPC, and MSA. Experience with validation for IQ, OQ and PQ
• Ability to translate customer quality requirements into executable plans
• Ability to create a culture and processes that foster change and learning
• Lean/ Six Sigma implementation experience preferred
• Skills in strategic planning, departmental management, group motivation, imagination and diplomacy are highly desirable pluses 

Sanmina is an Equal Opportunity Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity

JOB DESCRIPTOR

QA/QC Engineer : Develops, evaluates, revises, and applies technical quality assurance protocols/methods to inspect and test in-process raw materials, production equipment, and finished products. Ensures activities and items are in compliance with both company quality assurance standards and applicable government regulations. Performs analysis and identifies trends in the inspection of finished products, in-process materials and bulk raw materials, and recommends corrective actions when necessary. Ensures that established manufacturing inspection, sampling and statistical process control procedures are followed. May assure compliance to in-house and/or external specifications and standards, such as GMPs and ISO regulations. Evaluates and analyzes the efforts in organizing, documenting, and interpreting inspection support documents and records.