📍 Job Overview

Job Title: Quality Systems Engineer/ Senior QSE - 6 month Fixed Term
Company: Fisher & Paykel Healthcare Ltd
Location: Howick, Auckland, New Zealand
Job Type: Temporary
Category: Quality Assurance / Quality Control
Date Posted: 2025-07-22
Experience Level: 2-5 years
Remote Status: On-site

🚀 Role Summary

Key Responsibilities: Provide technical engineering and quality system support for design assurance of new and existing products. Manage implementation of the Quality Management System (QMS) to maintain compliance and ensure product quality for effective and efficient product commercialization.
Key Skills: Quality Engineering, Design Controls, Risk Management, International Regulations (FDA, EUMDR), ISO 13485, ISO 14971, Communication, Influencing, Relationship Building.

📝 Enhancement Note: This role requires a strong understanding of medical device regulations and quality management systems to ensure product compliance and quality.

💻 Primary Responsibilities

Design Assurance: Collaborate with cross-functional teams to ensure design assurance of new and existing products within the RAC Invasive Ventilation & Humidification product group.
Quality Management System (QMS): Manage the implementation of the QMS to maintain compliance with relevant standards and regulations.
Design Controls: Support activities related to the use of design controls to ensure products meet quality and regulatory requirements.
Product Commercialization: Ensure product quality for effective and efficient product commercialization.
Stakeholder Communication: Liaise with internal and external stakeholders to ensure alignment with quality objectives and expectations.

🎓 Skills & Qualifications

Education: A tertiary qualification in Science or Engineering is required.

Experience: A minimum of 2 years of experience as a quality engineer in the medical device industry is required. Experience in quality assurance, quality control, or a related field is also valuable.

Required Skills:

Quality Engineering in the medical device industry
Design Controls and Risk Management
Knowledge of international regulations (FDA, EUMDR) and standards (ISO 13485, ISO 14971)
Excellent communication and influencing skills
Ability to build strong relationships across all organizational levels

Preferred Skills:

Experience with medical device regulations and quality management systems
Knowledge of relevant software tools and systems
Familiarity with product development processes and lifecycle management

📊 Web Portfolio & Project Requirements (N/A for this role)

💵 Compensation & Benefits

Salary Range: The salary range for this role is not specified. However, the average salary for a Quality Systems Engineer in New Zealand is approximately NZD 80,000 - 120,000 per year (source: Glassdoor, Payscale).

Benefits:

Active Social Clubs & Community Groups
In-House Training Programs
Purchasing Privileges for Fisher & Paykel Healthcare and Medela products
Free Parking
Beautiful Campus with Green Spaces
Subsidised Cafés
Access to State-of-the-Art Facilities

Working Hours: The working hours for this role are 40 hours per week, with flexible hours and maintenance windows as required.

📝 Enhancement Note: The salary range provided is an estimate based on industry standards and should be verified with the hiring organization.

🎯 Team & Company Context

🏢 Company Culture

Industry: Fisher & Paykel Healthcare is a world leader in the design, manufacture, and marketing of medical devices, exporting to over 120 countries globally.

Company Size: Fisher & Paykel Healthcare has approximately 4,000 employees worldwide, with a significant presence in New Zealand.

Founded: The company was founded in 1961 and has since grown into a global leader in medical devices.

Team Structure:

The Quality team works closely with Research & Development, Operations, and other departments to ensure product quality and compliance.
The team consists of Quality Engineers, Quality Systems Engineers, and other quality-related roles, with a focus on collaboration and continuous improvement.

Development Methodology:

Fisher & Paykel Healthcare follows a structured product development process, with a focus on design controls, risk management, and quality assurance.
The company is committed to maintaining compliance with relevant standards and regulations, including ISO 13485 and ISO 14971.

Company Website: https://www.fphcare.com/

📝 Enhancement Note: Fisher & Paykel Healthcare's commitment to quality and compliance is reflected in its team structure and development methodologies.

📈 Career & Growth Analysis

Web Technology Career Level: This role is at the intermediate level, requiring a solid understanding of quality management systems and medical device regulations.

Reporting Structure: The Quality Systems Engineer reports to the Quality Manager and works closely with cross-functional teams to ensure product quality and compliance.

Technical Impact: The Quality Systems Engineer plays a critical role in ensuring that products meet quality and regulatory requirements, directly impacting patient safety and product commercialization.

Growth Opportunities:

Technical Growth: Develop expertise in medical device regulations and quality management systems, with opportunities to specialize in specific product areas or technologies.
Leadership Growth: Demonstrate strong leadership skills and take on more responsibilities within the Quality team or other departments.
Career Progression: Progress to senior roles within the Quality team or move into other areas of the business, such as Operations or Research & Development.

📝 Enhancement Note: Fisher & Paykel Healthcare offers opportunities for technical and leadership growth, with a clear career progression path for quality professionals.

🌐 Work Environment

Office Type: Fisher & Paykel Healthcare's campus in East Tamaki, Auckland, features modern, open-plan offices with state-of-the-art facilities and a focus on collaboration and innovation.

Office Location(s): The East Tamaki campus is the primary location for this role, with other offices in New Zealand and internationally.

Workspace Context:

Collaboration: The workspace is designed to encourage collaboration and communication between teams, with shared spaces and meeting rooms.
Equipment: Employees have access to relevant software tools and systems, as well as any specialized equipment required for their role.
Flexibility: The work schedule is flexible, with the ability to work from home or on-site as required.

Work Schedule: The work schedule is typically Monday to Friday, with flexible hours and maintenance windows as required.

📝 Enhancement Note: Fisher & Paykel Healthcare's work environment is designed to support collaboration, innovation, and flexibility, with a focus on employee well-being and work-life balance.

📄 Application & Technical Interview Process

Interview Process:

Online Application: Submit your resume and cover letter through the careers website.
Phone Screen: A brief phone call to discuss your application and experience.
Technical Interview: A comprehensive interview focusing on your technical skills, experience, and understanding of quality management systems and medical device regulations.
Final Interview: A final interview with the hiring manager to discuss your fit for the role and the team.

Portfolio Review Tips: (N/A for this role)

Technical Challenge Preparation: (N/A for this role)

ATS Keywords: (N/A for this role)

📝 Enhancement Note: The interview process for this role focuses on technical skills and cultural fit, with a strong emphasis on quality management systems and medical device regulations.

🛠 Technology Stack & Web Infrastructure (N/A for this role)

👥 Team Culture & Values

Quality Values:

Patient Focus: A commitment to improving patient care and outcomes through inspired and world-leading healthcare solutions.
Innovation: A drive to continuously improve and innovate, with a focus on staying at the forefront of medical device technology.
Collaboration: A culture of teamwork and collaboration, with a focus on cross-functional collaboration and knowledge sharing.
Accountability: A commitment to taking ownership and responsibility for our actions and their impact on patients, customers, and the business.

Collaboration Style:

Cross-Functional Integration: Fisher & Paykel Healthcare encourages collaboration between teams, with a focus on breaking down silos and working together to achieve common goals.
Code Review Culture: The Quality team has a strong code review culture, with a focus on continuous improvement and knowledge sharing.
Knowledge Sharing: Fisher & Paykel Healthcare fosters a culture of knowledge sharing, with regular training and development opportunities.

📝 Enhancement Note: Fisher & Paykel Healthcare's quality values and collaboration style are integral to its success as a global leader in medical devices.

⚡ Challenges & Growth Opportunities

Technical Challenges:

Regulatory Compliance: Staying up-to-date with and maintaining compliance with international regulations and standards.
Product Complexity: Managing the quality of complex medical devices with multiple components and systems.
Cross-Functional Collaboration: Working effectively with cross-functional teams to ensure product quality and compliance.

Learning & Development Opportunities:

Technical Skills: Develop expertise in medical device regulations, quality management systems, and relevant software tools and systems.
Leadership Skills: Build leadership skills through mentoring, coaching, and project management opportunities.
Career Progression: Progress to senior roles within the Quality team or move into other areas of the business, such as Operations or Research & Development.

📝 Enhancement Note: Fisher & Paykel Healthcare offers opportunities for technical and leadership growth, with a clear career progression path for quality professionals.

💡 Interview Preparation

Technical Questions:

Regulatory Compliance: Questions related to international regulations, standards, and compliance requirements.
Quality Management Systems: Questions related to design controls, risk management, and quality assurance processes.
Problem-Solving: Scenario-based questions that test your ability to identify and resolve quality issues.

Company & Culture Questions:

Quality Values: Questions related to Fisher & Paykel Healthcare's quality values and how you would apply them in your role.
Collaboration Style: Questions related to Fisher & Paykel Healthcare's collaboration style and how you would contribute to a culture of teamwork and knowledge sharing.
Career Growth: Questions related to your long-term career goals and how this role fits into your plans.

Portfolio Presentation Strategy: (N/A for this role)

📝 Enhancement Note: The interview process for this role focuses on technical skills, cultural fit, and long-term career goals, with a strong emphasis on quality management systems and medical device regulations.

📌 Application Steps

To apply for this Quality Systems Engineer/ Senior QSE - 6 month Fixed Term position:

Submit your resume and cover letter through the Fisher & Paykel Healthcare careers website.
Prepare for the phone screen by reviewing your application and experience.
Research Fisher & Paykel Healthcare's quality values and collaboration style to demonstrate your cultural fit.
Prepare for the technical interview by reviewing your technical skills and experience with quality management systems and medical device regulations.
Practice common interview questions and develop your own questions to ask the interviewer.

⚠️ Important Notice: This enhanced job description includes AI-generated insights and industry-standard assumptions. All details should be verified directly with the hiring organization before making application decisions.

Quality Systems Engineer/ Senior QSE - 6 month Fixed Term