Job Description Summary

As directed by the Quality Manager, the Quality Engineer is accountable for supporting new product development and product maintenance through the application of Quality engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements.

Job Description

Educational Background

Bachelor's degree in mechanical engineering, biomedical engineering or related engineering discipline.

Professional Experience

• Participates in design control activities of medical device products. Ensures proper design and development control and its documentation as per ISO 13485/ FDA QSR Quality System.
• Leads or supports Risk Management in accordance with ISO14971.
• Contributes as a team member on development projects carrying out assigned quality assurance responsibilities in a timely, diligent, and professional manner.
• Creates, implements changes to, and maintains controlled documents as needed (e.g., SOPs, Specifications, Methods, etc.) to ensure strict compliance of R&D functional operation with ISO 13485/ 21 CFR 820 Quality System/ EN requirements.
• Supports continuous improvement of the Quality Systems.
• Applies Statistical tools to support product development process.
• Provides QS knowledge to organization as needed. Administers appropriate training as needed.
• Participates in the ongoing operations of QA/QS activities.

• Moderate knowledge of medical device regulations and practices (ISO 13485, FDA QSR, etc.).
• Practical and demonstrated experience of Quality or Reliability engineering, risk analysis, product development and verification/validation testing in the medical device industry.
• Demonstrated hands-on experience with Design Control procedures.
• Experience in a Phase-Gate development process.
• Experience in directly applying statistical methods for quality improvement.
• Moderate knowledge and understanding of process development, total quality tools, and continual improvement approaches.

• Good technical writing skills.
• Familiarity with statistical methods and analysis and/or Minitab software.
• Team player with excellent interpersonal and communication skills.

• Familiarity with Six Sigma methodology.
• Disciplined and well-organized in documentation (plans, requirements, drawings, design reviews, and test methods).
• Strong critical thinking, analytical, and problem-solving skills.

• Certified Quality Engineer (Preferred)
• Certified Six Sigma Green Belt and/ or Six Sigma Black Belt (Preferred)