Design Quality Engineer -Walpole, MA, 02032

Campus4Tech; Walpole (MA); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading company in professional training and coaching is seeking a Design Quality Engineer in Walpole, MA. This mid-senior level role requires collaboration on quality management for product design, ensuring compliance with quality systems, and leading quality improvement initiatives. Ideal candidates will have 2-5 years of experience in a regulated industry, particularly in medical devices and diagnostics, and will actively engage in internal and external audits.

Qualifications

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

Responsibilities

• Participate in design changes and assist engineering with validation testing.
• Monitor and report Quality Systems KPIs.
• Support internal and external audits as the subject matter expert.

Skills

Quality Engineering

Design Verification

Design Validation

CAPA

Auditing Processes

Education

Bachelor's degree in a related field

Job description

Design Quality Engineer - Walpole, MA, 02032

This role involves participating in the governance and execution of the Quality Management subsystem related to Design Change. The candidate will collaborate with cross-functional teams to promote and ensure compliance with Quality Systems concerning product design and development. Additionally, the role includes leading quality improvement projects to support quality testing (QT) and other business initiatives, including audits (internal/external), supplier quality, CAPA, and training.

Major Job Responsibilities

• Participate as a core team member on various design changes.
• Assist engineering partners in developing design verification and validation testing requirements, including protocols, test methods, acceptance criteria, and statistical plans/techniques.
• Support the development, monitoring, and reporting of Quality Systems KPIs, and help develop Quality Goals & Objectives across the Point of Care (POC) unit.
• Support internal and external audits, serving as the subject matter expert for Design Quality Assurance.

Required Knowledge/Skills, Education, and Experience

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

Additional Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Quality Assurance
• Industry: Professional Training and Coaching