Medical Device Quality Engineer

Job Description

Our client is seeking a highly skilled Medical Device Quality Engineer to join their dedicated quality team in Queenstown. This role is pivotal in ensuring that all medical devices manufactured meet the highest standards of safety, efficacy, and regulatory compliance. You will be involved in all aspects of the quality management system, including design controls, risk management, complaint handling, and CAPA management. This is an exceptional opportunity for a quality professional to contribute to the development and production of innovative medical technologies that improve patient care, working within a company that upholds stringent quality principles and fosters continuous improvement. Key Responsibilities Develop, implement, and maintain the Quality Management System (QMS) in accordance with ISO 13485 and other relevant medical device regulations (e.g., FDA 21 CFR Part 820). Lead and participate in design control activities, ensuring that product designs meet all specified requirements and safety standards. Conduct risk management activities, including FMEAs and risk assessments, throughout the product lifecycle. Investigate customer complaints, non-conformances, and deviations, implementing effective corrective and preventive actions (CAPAs). Participate in internal and external audits, ensuring compliance with regulatory requirements and company policies. Develop and validate test methods, sampling plans, and inspection procedures for raw materials and finished devices. Requirements Bachelor's degree in Engineering (Biomedical, Mechanical, Electrical) or a related scientific discipline. Minimum of 4 years of experience as a Quality Engineer in the medical device industry. Thorough understanding and practical application of ISO 13485, FDA QSR, and other relevant international medical device regulations. Experience with risk management tools (e.g., FMEA) and CAPA processes. Strong analytical, problem-solving, and project management skills. Excellent documentation and communication abilities. Benefits Competitive annual salary and potential for year-end bonuses. Comprehensive medical, dental, and vision insurance. Retirement plan contributions and life assurance. Opportunities for professional growth, certifications, and attending industry workshops. A supportive and quality-focused work environment with a strong commitment to employee well-being. #J-18808-Ljbffr