Senior Design Quality Engineer

Job Title: Trainer – Design Quality Engineering

Location: Remote

Job type: Part-time

Job Summary:

Design Quality Engineer Trainer

Key Responsibilities:

• Training Program Development:

• Develop and structure training modules for Design Quality Engineering covering design controls, risk management, documentation, and compliance standards.

• Delivery of Training:

• Conduct theoretical and practical sessions for design, R&D, and quality engineers on Design Quality tools and methodologies.

• Mentoring & Coaching:

• Guide engineers on implementing design quality best practices, CAPA, and DFMEA during product development and design transfer phases.

• Regulatory Compliance Training:

• Train teams on regulatory frameworks such as

  ISO 13485, ISO 14971, FDA 21 CFR Part 820, and EU MDR

  requirements.

• Design Review Facilitation:

• Support and simulate design reviews and audits to demonstrate effective application of design quality tools.

• Assessment & Certification:

• Evaluate participants’ learning outcomes, provide feedback, and certify competency levels.

• Continuous Improvement:

• Update training content regularly based on the latest regulatory changes, quality trends, and internal feedback.

• Cross-functional Collaboration:

• Work closely with R&D, Regulatory, Manufacturing, and QA teams to ensure alignment between design and quality standards.

Key Skills & Competencies:

• Strong knowledge of

  Design Controls

  ,

  Risk Management (ISO 14971)

  , and

  Design Verification & Validation

• Expertise in

  DFMEA / PFMEA

  ,

  Root Cause Analysis

  , and

  CAPA methodology

• Hands-on experience with

  QMS implementation

  under

  ISO 13485 / FDA QSR

• Ability to interpret engineering drawings, design documentation, and test reports
• Excellent communication, presentation, and mentoring skills
• Proficiency with tools such as

  SolidWorks, PTC Creo, Minitab

  , or equivalent software preferred
• Strong analytical and problem-solving skills
• Prior experience in

  training, coaching, or technical mentoring

  roles is highly desirable

Qualification & Experience:

• Bachelor’s or Master’s Degree in Mechanical, Biomedical, or Design Engineering
• Minimum

  10 years of experience

  in Design Quality, Product Development, or Quality Assurance
• Certified in

  ISO 13485 / Six Sigma / Risk Management / Quality Engineering (ASQ CQE)

  preferred
• Experience in

  medical devices, automotive, or aerospace

  industries preferred