Quality Engineer

Full-time / Permanent
Salaried
$75K - $125K

About Us:

Vander-Bend Manufacturing is a vertically integrated Contract Manufacturer specializing in low and medium volume component and product manufacture for the Medical, Semiconductor, data, telecommunications, and related industries. We have facilities in San Jose, Santa Clara, Stockton, Rancho Cordova, Wheeling, IL and a new location in the Atlanta, GA area. We serve the manufacturing needs of over 200 companies in Silicon Valley and beyond, producing Sheet Metal, Machined Parts, Cable Assembly, and Electro-Mechanical and Electronic Assemblies.

About this Opportunity:

The Quality Engineer will provide support for product/process quality activities within Vander-Bend Manufacturing. Areas of assignment may include: Product/Process improvement efforts, equipment validations, supplier quality performance and quality systems support.

Responsibilities:

• Investigate product and process failures, identify root cause and drive to implement corrective measures.
• Work with suppliers and Vander-Bend’s Supply Chain department to improve overall performance.
• Maintain metrics to evaluate process performance and work with Manufacturing/Engineering to ensure that objectives are met.
• Create/Update work instructions and procedures as needed.
• Lead and/or create equipment validation protocols and reports.
• Monitor QMS activities: Internal audits, CAPAs, complaints, KPI reviews etc.
• Coordinate PPQP activities (pFMEA, CP, Capability reports, GR&R etc.) – for special projects.
• Assist the Director of Quality in maintaining ISO 13485 QMS.

Qualifications:

• Bachelors’ degree in Quality/Mechanical/Industrial engineering or a closely related field,
• 2 years of work experience in a related field in a medical device or manufacturing environment.
• Additional experience may be substituted for the education requirement or advanced degree can be substituted for some of the experience.

Skills:

• Understand in depth quality systems, ISO 13485 and/or 9001 standards.
• Ability to create, review, and revise operating procedures, work instructions in English.
• Specific training and demonstrated success in applying quality problem solving method, such as fishbone diagrams, 5 why, FMEA, process capability analysis, hypothesis testing, DoE, SPC, etc.
• Minitab, JMP or other statistical software capabilities.