Quality Engineer

The Quality Engineer collaborates closely with the engineering team to identify and understand critical-to-quality design attributes and specifications. This role involves reviewing and releasing custom hardware, sub-project, and project DHF documentation to ensure compliance with all applicable regulatory requirements. The individual will contribute to the development, monitoring, and continuous improvement of ISO 13485 and 21 CFR 820 quality system procedures, supporting efficient compliance and alignment with company objectives.

Key Responsibilities:

• Provide quality assurance support during the design and development of medical device products, ensuring proper application of design/change controls, risk management, quality planning, and execution of design and development activities.
• Serve as a subject matter expert for subsystems such as Design Control, Risk Management, Design Verification, Design Validation, and Process Validation.
• Support internal Quality System enhancements and growth initiatives.
• Implement and maintain quality systems, policies, and procedures to ensure compliance with ISO 13485, cGMP, FDA regulations (including 21 CFR Part 11, 803, 806, and 820), and other relevant standards.
• Oversee quality aspects of internal and external process characterisation plans, protocols, and reports.
• Author, issue, and review regulated documentation to ensure adherence to current Good Manufacturing Practices and regulatory requirements.
• Review and approve project documentation for completeness and alignment with defined scope.
• Maintain knowledge of cGMP and FDA/EMA regulations.
• Assist with regulatory inspections conducted by FDA and international agencies.
• Perform additional duties as required.

Experience & Qualifications:

• Bachelor's degree in Engineering (or equivalent) with at least 6 years of experience in the regulated medical device industry, preferably in Quality Assurance supporting new product development.
• Strong understanding of Quality Systems and practical experience with ISO 13485, FDA Quality System Regulations, GMP, GDP, ISO 14971, and related standards.
• Familiarity with design and development principles, risk management, FDA 510(k) submissions, and ISO regulations.
• Experience with MasterControl is a plus.

Skills & Competencies:

• Advanced proficiency in Microsoft Office applications.
• Strong written and verbal communication skills.
• Excellent organisational abilities.
• Ability to work independently and collaboratively within a team environment.