Quality Engineer

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.

With assistance from senior Quality Management, the Quality Engineer will implement and maintain a Quality Management System compliant with ISO 13485:2016. Conduct internal and supplier audits as required.

• Incorporate ISO standards (ISO 13485:2016, ISO 9001, ISO 14001) through the product life cycle, designing and developing the required inspection and process control methodologies
• Assist in the maintenance of an AS9100/ISO 9001compliant quality system.
• Assist in the maintenance of an ANSI ESD S20.20 program.
• Assist in the maintenance of a TL9000 compliant 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.
• Manage multiple projects simultaneously without supervision. This includes:
  • Conducting Audits to ensure conformance and effectiveness of the Quality System
  • Feedback and improvement on Customer ‘Supplier Quality Issues’.Failure analysis with suppliers on failures In-process and field failures.
  • Supporting the CAPA program to facilitate the timely closure of corrective and preventative actions
  • Support incoming inspection
  • Support Documentation SOP’s
  • Support the ESD program
• Perform investigations for issues affecting product quality.
• Works with project engineers to ensure that inspection process capabilities have been verified and appropriately documented.
• Support quality process definition, set up, verification and improvement
  • Data collection, analyzing and reporting
  • Customer complaints and improvement processes
  • Pareto and trend analysis as required Quality Metrics
  • First Article Inspections and Reporting
  • RMA, review, approval analysis and improvement
  • Customer Interface on Quality Issues
  • Identify improvements through Quality review and meetings on Quality, Yield, flow, documentation, control etc

MEASUREMENTS:

• Yields at Key Process Steps (ICT, Functional Test, Final Test, OBA)
• CARs, SCAR’s, PAR’s and CCN’s

• Bachelor’s Degree in Electrical, Electronic, Industrial Engineering or similar.
• Minimum 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 TL9000, ANSI EDS S20.20, ISO
  14001).
• 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.

• The compensation range for this position is $70,000 - $90,000 annually.
• This position is for an existing vacancy.
• The hiring process for this position does not use Artificial Intelligence (AI).

Sanmina welcomes and encourages applications from persons with disabilities. In accordance with the guidelines established under the Accessibility for Ontarians with Disabilities Act (AODA), accommodations are available on request for candidates taking part in all aspects of the selection process.