Global Design Quality Leader – Medical Devices

Proclinical; Auckland; On-site; NZD 150,000 - 210,000; Full time

Job summary

Proclinical is seeking a Senior Design Quality Manager to lead the Design Assurance and Design Transfer for medical device portfolios. You will shape quality strategy across Respiratory, Infant, and Anaesthesia products and ensure alignment with global regulatory requirements.

You will guide product design controls, change control, and quality improvement initiatives while leading a cross‑functional team of professionals. This role offers global collaboration and a pivotal impact on patient care.

Qualifications

• Expertise in medical device quality management systems and global regulatory requirements.
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• job_responsibilities_description:[
• Lead the development and execution of quality strategies for product development portfolios.
• Ensure compliance with regulatory requirements, company quality objectives, and market acceptance standards.
• Oversee product design control plans, product change control plans, and product quality improvement initiatives.
• Manage and develop a high-performing team across a diverse portfolio of Class I to III medical devices.
• Engage with global regulators and ensure alignment with international standards.
• Collaborate with senior management to prioritize and implement quality strategies.

Responsibilities

• Lead the development and execution of quality strategies for product development portfolios.
• Ensure compliance with regulatory requirements, company quality objectives, and market acceptance standards.
• Oversee product design control plans, product change control plans, and product quality improvement initiatives.
• Manage and develop a high-performing team across a diverse portfolio of Class I to III medical devices.
• Engage with global regulators and ensure alignment with international standards.
• Collaborate with senior management to prioritize and implement quality strategies.

Skills

QMS expertise

Regulatory compliance

Design control

Change control

Quality improvement

People management

Global regulatory engagement

Cross-geography collaboration

Product development knowledge

Education

Bachelor's degree in engineering/science/business or related field

Job description

Proclinical is seeking a Senior Design Quality Manager to lead the Design Assurance and Design Transfer for medical device portfolios. You will shape quality strategy across Respiratory, Infant, and Anaesthesia products and ensure alignment with global regulatory requirements.

You will guide product design controls, change control, and quality improvement initiatives while leading a cross‑functional team of professionals. This role offers global collaboration and a pivotal impact on patient care.