About the Role:

We are seeking a highly motivated and detail-oriented Graduate Quality Engineer to join our team at [Company Name], a leading innovator in the medical device industry. This is an exciting opportunity for a recent graduate with a passion for quality systems, continuous improvement, and regulatory compliance to gain hands-on experience in a fast-paced, highly regulated environment.

Key Responsibilities:

• Support the implementation and maintenance of the Quality Management System (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory requirements.
• Assist in the investigation of non-conformances, complaints, and CAPAs, including root cause analysis and implementation of corrective and preventive actions.
• Participate in internal audits, supplier audits, and regulatory inspections.
• Help ensure compliance with document control, training records, and change control procedures.
• Work closely with cross-functional teams (R&D, Manufacturing, Regulatory, etc.) to support quality assurance activities throughout the product lifecycle.
• Contribute to risk management activities, including FMEA updates and design reviews.
• Support validation efforts for equipment, processes, and software (IQ/OQ/PQ protocols).
• Assist in the preparation of quality metrics and reports for management review.
• Engage in continuous improvement projects to enhance product quality and operational efficiency.

Qualifications & Requirements:

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
• Strong interest in quality assurance and regulatory compliance in the medical device or healthcare sector.
• Familiarity with ISO 13485, FDA QSR, and Good Documentation Practices (GDP) is a plus.
• Excellent attention to detail and strong organizational skills.
• Proficient in Microsoft Office tools (Excel, Word, PowerPoint).
• Strong written and verbal communication skills.
• Ability to work independently and as part of a cross-functional team.