QA Engineer

About the role

Sanmina Corporation is a leading integrated manufacturing solutions provider serving the fastest-growing segments of the global Electronics Manufacturing Services (EMS) market. The Quality Engineer provides quality engineering and assurance to ensure products and services exceed customer requirements and expectations. This role works in conjunction with other business and engineering disciplines using a cross-functional approach to ensure compliance with applicable Quality Management Systems, standards, and regulations.

Responsibilities

• Lead quality planning activities for new product release projects, including verification and validation plans.
• Contribute 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.
• Assist in the maintenance of an ISO 13485 compliant system.
• Conduct internal and supplier audits as required.
• Analyze reports and returned products and recommend corrective action.
• Provide day-to-day quality engineering support for specific customer programs.
• Interface closely with operations, manufacturing, test engineering, and 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, and corrective/preventive action responses.
• Serve as the 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 of 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 (e.g., PFMEA, Control Plans, SPC, MSA).
• Experience with validation processes (components, process, and design).
• Lean/Six Sigma implementation experience preferred.
• Able to define and/or interpret problems, collect data, establish facts, and draw valid conclusions.
• Effectively communicate with co-workers, customers, and suppliers.
• Interpret industry standards, technical instructions, drawings, and specifications.
• Thorough understanding of problem-solving and quality improvement tools and techniques, including management and planning tools, quality tools, preventive and corrective actions, and overcoming barriers to quality improvements.

Skills

• 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.

Qualifications

• ASQ Certification as a Quality Engineer or Six Sigma Green/Black Belt desired.