QSE Manager – Design Assurance (Medical Devices)

Fisher Paykel Healthcare; Howick; On-site; NZD 127,000 - 140,000; Full time

Benefits offered by this job

Employee share plan

Profit sharing

Life and income protection

Health insurance discount

Social clubs

Training programs

Purchasing privileges

Banking discounts

Free parking

EV charging facility

Salary review

Internal promotion

Job summary

Fisher & Paykel Healthcare, a world leader in medical devices, is seeking a QSE Manager to lead the Quality System Engineers and ensure design teams meet regulatory requirements.

The role focuses on providing technical engineering and quality system support for multiple product groups, with a strong emphasis on leadership and change management within a fast-paced R&D environment in Auckland.

Qualifications

• Engineering degree or related technical field.
• Minimum 5 years of medical devices experience.
• Strong leadership experience.
• Deep understanding of design controls and regulatory requirements (ISO13485, ISO14971, FDA CFR 820).

Responsibilities

• Lead a team of Quality System Engineers providing technical engineering and quality system support for design teams.
• Ensure compliance with regulatory requirements and standards.
• Collaborate with product design, operations, marketing and clinical teams to drive quality across development stages.
• Drive continuous improvement and change management within the QA and design assurance functions.

Skills

People leadership

Quality Assurance

Design controls

Medical devices

Regulatory knowledge

Education

Engineering degree

Job description

Fisher & Paykel Healthcare, a world leader in medical devices, is seeking a QSE Manager to lead the Quality System Engineers and ensure design teams meet regulatory requirements.

The role focuses on providing technical engineering and quality system support for multiple product groups, with a strong emphasis on leadership and change management within a fast-paced R&D environment in Auckland.