Design Quality Engineer -Walpole, MA, 02032

Campus4Tech; Walpole (MA); On-site; USD 75,000 - 95,000; Full time

Job summary

A leading company in the medical device industry is seeking a Design Quality Engineer to enhance Quality Systems compliance for product design. This role involves collaboration with cross-functional teams and leading quality improvement projects to ensure adherence to regulations. The ideal candidate will have experience in an FDA regulated environment, driving quality in design and development.

Qualifications

• 2-5 years of experience in Quality Engineering or similar role.
• Experience in an FDA regulated industry, preferably medical device.
• Knowledge of CAPA and auditing processes.

Responsibilities

• Participate as a core team member on various design changes.
• Assist in the development of design verification and validation testing requirements.
• Support internal and external audit needs as the subject matter expert.

Skills

Collaboration

Quality Systems Compliance

Statistical Analysis

Auditing

Job description

Description

The Design Quality Engineer will participate in the governance, and execution of the Quality Management sub-system element of Design Chnage. Specifically, the person will be required to interact and collaborate with cross functional teams to promote and drive Quality Systems compliance regarding product design and development activities. Additionally, this role will lead specific quality improvement projects as required to support QT and other business initiatives including, but not limited to audits (internal / external), supplier quality, CAPA, and training.

Major Job Responsibilities

• Participate as a core team member on various design changes
• Provide assistance to the engineering partners in the development of design verification and validation testing requirements including protocol development, test methods, acceptance criteria, and statistical plans / techniques;
• Support the development, monitoring and reporting of Quality Systems key performance indicators (KPIs), which will include assisting in the development of Quality Goals & Objectives across POC.
• Support internal and external audit needs while serving as the subject matter expert for Design Quality Assurance
  
  

Required Knowledge/Skills, Education, And Experience

2-5 years of experience in a Quality Engineering or similar role within an FDA regulated industry preferably medical device and diagnostics that includes experience with CAPA and auditing processes.