Senior Quality Systems Engineer - Medical Devices

Fisher & Paykel Healthcare; Auckland; On-site; NZD 120,000 - 180,000; Full time

Benefits offered by this job

Employee share purchase scheme

Discretionary profit share

Generous parental leave

Life, illness & income protection

Job summary

Fisher & Paykel Healthcare seeks a Senior Quality Systems Engineer to join the Design Quality Team supporting the Airvo product group. You will provide expert quality guidance, collaborate with Product Development and release new products to markets while maintaining conformance of existing products.

You will lead activities related to design controls, drive QMS improvements, and act as a SME for quality systems, enabling robust design assurance and compliant product commercialization.

Qualifications

• Minimum 5 years of experience in Quality Engineering or a related technical field.
• Experience in a highly regulated manufacturing/design environment; medical device experience is highly advantageous.
• Strong knowledge of medical device regulations; electronic-focused regulations preferred.
• Proven ability to apply quality principles to support business objectives and product outcomes.
• Experience leading quality initiatives, projects or complex compliance activities.

Responsibilities

• Provide expert quality guidance to the design and development teams.
• Lead design controls and ensure robust design assurance for new and existing products.
• Drive the implementation and continuous improvement of the Quality Management System (QMS).
• Ensure product quality to support efficient product commercialization across markets.
• Identify and implement QMS improvements and provide guidance across the organisation.

Skills

Quality engineering

Regulatory compliance

Medical devices

Quality management systems

Leadership

Communication

Problem solving

Cross-functional collaboration

Education

Science or Engineering degree

Job description

Fisher & Paykel Healthcare seeks a Senior Quality Systems Engineer to join the Design Quality Team supporting the Airvo product group. You will provide expert quality guidance, collaborate with Product Development and release new products to markets while maintaining conformance of existing products.

You will lead activities related to design controls, drive QMS improvements, and act as a SME for quality systems, enabling robust design assurance and compliant product commercialization.