Quality Engineer

Job Description

Job Description

About the Role

Our client is looking for a driven Quality Engineer to help strengthen and maintain their Quality Management System (QMS) in alignment with FDA regulations, ISO 13485, and related industry standards. This individual will play a vital role in ensuring regulatory compliance, supporting both internal and external audits, and contributing to the design, development, and validation of innovative medical device products.

This position is ideal for someone who takes initiative, enjoys solving complex problems, and is passionate about maintaining the highest standards of product quality and patient safety.

Key Responsibilities

Ensure adherence to ISO 13485 , 21 CFR Part 820 , and internal quality procedures.

Prepare for and support regulatory, customer, and notified body audits.

Participate in supplier qualification activities and conduct supplier audits when required.

Serve as a quality liaison for designated customers and vendors, managing communication and documentation.

Review design inputs, risk assessments, and validation protocols for new product development projects.

Assist with creating and executing verification and validation plans to confirm product performance.

Conduct product and process risk analyses per ISO 14971 guidelines.

Develop Quality Plans and Master Validation Plans to ensure effective project execution.

Support ongoing quality functions, including nonconformance investigations, MRB reviews, deviations, and CAPA activities.

Coordinate and manage quality deliverables, ensuring timely documentation and approvals.

Perform additional quality and compliance-related tasks as needed to maintain system integrity.

Qualifications

Education :

Bachelors degree in Engineering , Quality Assurance , or a related technical discipline.

Experience :

Minimum 1 year of experience in medical device quality, manufacturing quality, or regulatory compliance.

Knowledge & Skills :

Familiarity with FDA QSR and ISO 13485 standards for Class I, II, and III devices.

Understanding of risk management principles under ISO 14971.

Experience using quality management software, data analysis tools, and Microsoft Office applications.

Skilled in root cause analysis and problem-solving techniques (e.g., 5 Whys, Fishbone Diagrams).

Strong communication, organization, and time management skills.

Preferred Experience

5+ years of experience in quality engineering or assurance within the medical device field.

ASQ certifications such as CQE or CQA are highly desirable.

Working knowledge of sterilization validation standards ( ISO 11135 , ISO 17665 ).

Familiarity with cleanroom classification and monitoring requirements under ISO 14644 .

Why Join Our Client?

Our client is a growing organization known for its commitment to innovation, collaboration, and quality excellence. Youll join a team that values continuous improvement, technical curiosity, and the impact their products have on improving patient lives. This role offers strong professional development opportunities, competitive compensation, and a chance to contribute to meaningful advancements in medical technology.

Salary : $100,000 - $125,000