Senior Medical Device Design Quality Lead

Scientific & Technical Recruitment; Auckland; On-site; NZD 150,000 - 190,000; Full time

Benefits offered by this job

Senior role

Collaborative environment

Innovation focus

Quality-driven development

Leadership opportunities

Job summary

Scientific & Technical Recruitment is seeking a Design Quality Manager for medical devices in Auckland. This senior role leads the Design Quality function across development, design controls, risk management and quality systems to ensure global regulatory compliance.

You'll work closely with R&D and Regulatory teams, shaping quality processes, mentoring the Design Quality team and driving robust design and risk management through all stages from design to commercialisation.

Qualifications

• Bachelor's degree in science, engineering or a relevant technical discipline.
• 8+ years of quality experience within the medical device industry, including strong design and development quality experience.
• Around 5+ years of leadership experience coaching, developing and building capability within a team.
• Strong working knowledge of medical device design controls, risk management, ISO 13485, cGMP and FDA 21 CFR Part 820.
• Excellent communication and problem-solving skills with capability to engage across R&D, Regulatory and senior leadership; FDA/ISO audit experience is highly regarded.

Responsibilities

• Lead, mentor and develop the Design Quality team, building capability, accountability and strong quality ownership.
• Provide quality leadership across medical device design and development, including design controls, risk management and design changes.
• Partner with R&D across design inputs and outputs, verification, validation, design transfer and cross-functional design reviews.
• Oversee quality activities relating to usability, software, electrical systems, materials, specifications and related design documentation.
• Maintain and continuously improve the QMS to ensure compliance and readiness for audits and inspections.

Skills

Leadership

Communication

Quality management

Problem-solving

Education

Bachelor's degree in science/engineering

Job description

Scientific & Technical Recruitment is seeking a Design Quality Manager for medical devices in Auckland. This senior role leads the Design Quality function across development, design controls, risk management and quality systems to ensure global regulatory compliance.

You'll work closely with R&D and Regulatory teams, shaping quality processes, mentoring the Design Quality team and driving robust design and risk management through all stages from design to commercialisation.