Design Quality Engineer

Design Quality Engineer

  Not Disclosed

  Walpole, MA (100% Remote)

  9 Months

  Not Disclosed

  Not Disclosed

  Healthcare

  $38/hour - $43/hour

Job Description

Specific Requirements

The Design Quality Engineer will participate in the governance, and execution of the Quality Management sub-system element of Design Change. 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.



Technical Skills:

Essential: Basic proficiency in Microsoft Office.
Trainable: SAP, Azure, DevOps.

Experience:

2+ years with a bachelor's degree, or
5+ years with an associate's degree,
You can include internships in the quality field.

Desired Soft Skills:

Strong communication skills for effective interaction with internal team members and managers.
Self-driven and proactive, not afraid to ask questions.

Education Requirements:

Minimum: Associate's degree with relevant field experience in a quality role.
Preferred: Bachelor's degree (not mandatory).


Work Hours:
Standard Hours: 8 AM to 5 PM, with some flexibility in start time.

Position Details:

Work Arrangement: 100% remote, must be in the Eastern Standard Time (EST) or Central Time (CST) zones.
VIVA is an equal opportunity employer. All qualified applicants have an equal opportunity for placement, and all employees have an equal opportunity to develop on the job. This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.