Design Transfer Quality Engineer

Fisher & Paykel Healthcare; Auckland; On-site; NZD 85,000 - 95,000; Full time

Benefits offered by this job

Employee share purchase scheme

Profit sharing (bi-annual)

Life, CI & income protection insurance

Discounted health insurance

Free parking

Annual salary review

Internal promotions

Job summary

Fisher & Paykel Healthcare is seeking a Quality Engineer in Auckland to support the Design Transfer Quality Team. You will collaborate with quality design, manufacturing and engineering to develop new manufacturing processes and introduce new products to production.

The role requires 2+ years in a regulated medical device environment, knowledge of FDA and ISO standards, and a degree in Science or Engineering. Competitive benefits and a dynamic campus environment await.

Qualifications

• Minimum 2 years in the medical device industry or a highly regulated field.
• Experience in quality engineering, design assurance, manufacturing or NPI.
• Understanding of FDA and international regulations and standards.
• Tertiary qualification in Science, Engineering or relevant discipline.

Responsibilities

• Provide quality engineering support for New Product Introduction (NPI) and capacity increase projects.
• Act as the primary QA resource for process development teams, assisting with problem-solving and reviews.
• Ensure compliance with quality and regulatory requirements (FDA, ISO 13485, ISO 14971).
• Design and implement continuous improvement projects for the QMS.

Skills

Quality engineering

NPI experience

Regulatory knowledge

Education in Science/Engineering

Education

Tertiary qualification in Science or Engineering

Job description

Fisher & Paykel Healthcare – Auckland, North Island

Our story began more than 50 years ago, when one doctor and two engineers designed a better way to care. Today, we are a thriving global business, and our products, used in acute and chronic respiratory care, surgery and the treatment of obstructive sleep apnea, make a difference to millions of patients every year.

Care to Make a Difference?

Join a team of good people doing good work with intent. People like you, who care to make a difference.

About the Role

We have an exciting opportunity for a Quality Engineer to join our Design Transfer Quality Team supporting our RAC product division. You will be working in partnership with our quality design, manufacturing, and engineering teams to support the design and development of new manufacturing processes and to facilitate the introduction of new products to manufacturing.

If you excel in a collaborative environment and aspire to contribute to our company's growth, we want to hear from you!

In this role you will:

• Provide quality engineering support for New Product Introduction (NPI) and capacity increase projects.
• Act as the primary quality assurance resource for process development teams, and other stakeholders, assisting with problem-solving, reviewing process inputs, outputs, process validation, design reviews, process release, and continuous improvement initiatives.
• Utilize your knowledge of international regulations (FDA, EUMDR) and standards (ISO 13485, ISO 14971) to help the product group comply with quality and regulatory requirements.
• Ensure released products meet specifications through effective process verification and validation, consistently aligning with the intended use.
• Design and implement continuous improvement projects for ongoing enhancement and compliance of the Quality Management System (QMS).

About You

Required skills and experience include:

• A minimum of 2 years of experience in the medical device industry or a highly regulated industry equivalent.
• Experience in quality engineering, design assurance, manufacturing or NPI.
• An understanding of FDA and international regulations and standards.
• A tertiary qualification in Science, Engineering or relevant discipline.

Why Join Us?

• Supportive Team: Be part of an experienced and collaborative team.
• Dynamic Projects: Gain exposure to multiple and diverse projects, facilitating rapid learning and professional growth.
• Cross-Functional Collaboration: Work with diverse teams, stakeholders, and functions, expanding your professional network and expertise.
• Employee share purchase scheme
• Discretionary bi-annual Profit share
• Life, Critical illness and Income Protection Insurance
• Discounted Health Insurance
• Active Social clubs & community groups
• In-house training programs from external providers
• Purchasing privileges for Fisher & Paykel Healthcare products
• Banking and Insurance discounts
• Free Parking
• Beautiful campus with green spaces including EV charging stations and end of trip facilities to encourage lower-impact transport choices
• Annual Salary Review
• High rates of internal promotion

About Us

Fisher & Paykel Healthcare is a world leader in the design, manufacture, and marketing of medical devices, exporting to over 120 countries globally. We are an iconic New Zealand company with a consistent growth strategy ensuring an expanding range of innovative devices for use in respiratory care, acute care and the treatment of obstructive sleep apnea.

We focus on nurturing a positive and inclusive culture based on trust and respect. In New Zealand, our employee-led communities, Spectra (rainbow), Manaaki (Māori) and Women in Engineering play an important role in this culture. We also have a commitment to creating a positive lasting impact on society, shown by our support of New Zealand organisations such as Diversity Works NZ, Pride Pledge and Global Women.

This is a full-time, permanent position (40 hour week) with a starting salary range of $85,000 - $95,000. The role is based in our Auckland office in Highbrook Drive in East Tamaki