Quality Engineer

Socket.dev; Rancho Cordova (CA); On-site; USD 90,000 - 115,000; Full time

Job summary

Vantedge Medical is seeking a Quality Engineer to support product and process quality activities within our medical device manufacturing environment onsite in Rancho Cordova, CA. You will drive CAPA, quality reporting, supplier quality, and PPAP/validation efforts, collaborating with manufacturing and supply chain to meet performance targets.

You should have a 4-year degree in Quality/Mechanical/Industrial engineering and at least 2 years in medical device or manufacturing settings, with strong

Qualifications

• Bachelor's degree in Quality/Mechanical/Industrial engineering or closely related field.
• Minimum 2 years' experience in medical device/manufacturing.
• Strong understanding of ISO 13485 and ISO 9001.
• Ability to create, review, and revise procedures in English.
• Experience with quality problem-solving methods (FMEA, 5 Why, Fishbone, DoE, SPC).
• Experience with CAPA, complaints, and yield reporting.

Responsibilities

• Generate internal quality reports based on CAPA, complaints and yield. Propose and drive product/process improvement initiatives.
• Work with suppliers and Supply Chain department to improve overall performance.
• Maintain metrics to evaluate process performance and work with manufacturing to ensure that expectations are met.
• Coordinate PPQP activities (pFMEA, CP, Capability reports, GR&R etc.).
• Assist the Director of Quality in maintaining ISO 13485 QMS.
• Create/Update work instructions and procedures as needed.
• Lead and/or create equipment validation protocols and reports.
• Undertake additional responsibilities or activities as required by Director of Quality.

Skills

Quality systems knowledge

Problem solving methods

Statistical software

English documentation

Education

Bachelor's degree in Quality/Mechanical/Industrial engineering

Tools

Minitab

JMP

Job description

Quality Engineer

Full-time | Permanent | Onsite

Salaried | $90k - $115k

*We are not accepting candidates from third party agencies.

About Us:

Vantedge Medical is the premier metals-based med-tech solutions partner from concept to full-scale manufacturing. We are at the forefront of precision engineering and innovation, specializing in the development and manufacturing of vital components for medical markets such as Robotic Assisted Surgery, Orthopedics, Surgical Instruments, Dental, and more. Our teams work in unison, collaborating and problem-solving to serve the manufacturing needs of the top Medical Original Equipment Manufacturers (OEMs) around the globe. Making a difference in the lives of patients and their families drives us to go above and beyond every day. With a steadfast commitment to advancing medical technology, we take immense pride in the work we do – and have a lot of fun doing it.

About this Opportunity:

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

Responsibilities:

• Generate internal quality reports based on CAPA, complaints and yield. Propose and drive product/process improvement initiatives.
• Work with suppliers and Supply Chain department to improve overall performance.
• Maintain metrics to evaluate process performance and work with manufacturing to ensure that expectations are met.
• Coordinate PPQP activities (pFMEA, CP, Capability reports, GR&R etc.).
• Assist the Director of Quality in maintaining ISO 13485 QMS.
• Create/Update work instructions and procedures as needed.
• Lead and/or create equipment validation protocols and reports.
• Undertake additional responsibilities or activities as required by Director of Quality.

Requirements

• 4-year degree in Quality/Mechanical/Industrial engineering or a closely related field.
• A minimum of 2 years of work experience in a related field in a medical device or manufacturing environment.
• 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.