Job Title: Design Engineering Quality Manager

Job Purpose:

The Design Engineering Quality manager mentors the Quality Engineers, providing leadership and insight during new product development to ensure that quality processes are clearly defined and consistent with the product classification and with ISO 13485. This position ensures that defined quality requirements are met throughout the development process and during transfer to manufacturing. The successful candidate will have experience managing agency/customer/internal audits. Strong leadership and customer-facing skills are required.

Nature of Duties:

• Interfacing regularly with a world-wide team of Quality Engineers (QEs). The QEs provide quality engineering services to product development projects and ensuring that design history files comply with company policies, 13485-based QMS procedures and external regulations.
• Assisting product development teams with the development of essential design control deliverables including: product requirement specifications, performance analysis, risk analysis, failure mode and effects analysis (FMEA), design verification and validation, documentation and product release.
• Training QEs in the review of engineering drawings and documentation to ensure that quality requirements are met while retaining design intent.
• Support the QE’s as they attend product development team meetings, design reviews, assist in writing technical reports for submission to regulatory agencies and assisting in authoring test plans and verification protocols.
• Understanding quality engineering tools including: FMEA, measurement system analysis, computer-based inspection methods, process verification/validation plans, statistical techniques (Cpk, SPC), Design of Experiments (DOE) and problem solving (i.e. DMAIC).
• Assisting suppliers with the interpretation of quality requirements including verification/validation planning and execution and first production run requirements.
• Supporting the Quality System in respect to both design control and support of manufacturing operations by developing design-specific Standard Operating Procedures (SOPs), implementing and training others for product-specific Work Instructions (WIs).
• Supervise the training of members and new hires relative to our Quality Management System, and maintain training records.
• Manage audits by external agencies, internal corporate and division quality groups.
• Manage and approve corrective and preventative actions.
• Participate in customer audits and support sales activities when required, representing Sanmina’s quality systems, procedures and controls. 

Education/Experience:

• Bachelor’s Degree
• Minimum of 10 years directly related experience
• Knowledge and experience with quality, safety and regulatory requirements
• Some travel may be required both international and domestic