Senior Medical Device Quality Engineer | QMS & CAPA Lead

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

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.