Medical Device Quality Engineer

Placements24; Queenstown; On-site; NZD 90,000 - 130,000; Full time

Benefits offered by this job

Competitive salary

Medical insurance

Retirement plan

Professional development opportunities

Job summary

Placements24 in Queenstown seeks a Medical Device Quality Engineer to join our client’s dedicated quality team. You will oversee the QMS, design controls, risk management, and CAPA, ensuring devices meet safety and regulatory standards and patient needs.

You will work with ISO 13485, FDA QSR, and global medical device regs, lead audits, and drive continuous improvement through robust documentation and collaboration with cross-functional teams.

Qualifications

• Bachelor's degree in Engineering (Biomedical, Mechanical, or Electrical) or related field.
• Minimum 4 years' experience as a Quality Engineer in the medical device industry.
• Strong knowledge of ISO 13485, FDA QSR, and other international medical device regulations.
• Experience with risk management tools (FMEA) and CAPA processes.

Responsibilities

• Develop, implement, and maintain the QMS.
• Lead design control activities to ensure safety and compliance.
• Conduct risk management activities including FMEA and risk assessments.
• Investigate complaints, non-conformances, and deviations; implement CAPAs.
• Participate in internal and external audits; ensure regulatory compliance.
• Develop and validate test methods, sampling plans, and inspection procedures.

Skills

Analytical thinking

Problem solving

Project management

Documentation

Communication

Education

Bachelor's degree in Engineering (Biomedical, Mechanical, Electrical) or related field

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.