Senior Quality Systems Engineer – Med Devices Leader

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

Benefits offered by this job

Employee share purchase scheme

Profit share & salary review

Generous parental leave

Health Insurance & life protection

Job summary

Fisher & Paykel Healthcare in Auckland, New Zealand, is seeking a Senior Quality Systems Engineer to lead Design Quality and QMS activities across our Infant Care, NIV, IVH and OSA product streams from our head office in Auckland. Immigration and relocation support will be provided to preferred candidates.

You’ll partner with Regulatory, Clinical, Operations and Product Development to ensure safe, effective and compliant devices while driving ongoing quality improvements and lifecycle activities.

Qualifications

• Experience or knowledge across Design Quality/Quality Engineering in medical devices.
• Knowledge of Design Controls and QMS incl. ISO 13485 and FDA.
• Proficiency in risk management per ISO 14971.
• Experience with verification and validation activities.
• Experience with change control and lifecycle activities.
• Ability to use data and statistics for risk-based decisions.
• Familiar with CAPA, usability engineering and EU regulatory requirements.
• Relevant Science or Engineering degree.

Responsibilities

• Provide quality leadership across product development and lifecycle.
• Act as SME in Design Controls and the QMS.
• Influence cross-functional teams on quality and risk decisions.
• Identify and drive QMS and continuous improvement initiatives.
• Provide training and guidance to others.
• Take a holistic view of product quality, regulatory compliance and business needs.

Skills

Design Quality

Quality Engineering

Design Controls

Quality Management Systems

ISO 13485

FDA requirements

Risk management

ISO 14971

Verification & Validation

Change control

Product lifecycle

Data & statistics

CAPA

Usability engineering

Regulatory knowledge (EU/International

Science or Engineering qualification

Education

Science or Engineering degree

Job description

Fisher & Paykel Healthcare in Auckland, New Zealand, is seeking a Senior Quality Systems Engineer to lead Design Quality and QMS activities across our Infant Care, NIV, IVH and OSA product streams from our head office in Auckland. Immigration and relocation support will be provided to preferred candidates.

You’ll partner with Regulatory, Clinical, Operations and Product Development to ensure safe, effective and compliant devices while driving ongoing quality improvements and lifecycle activities.