Quality Engineer - Manufacturing

Fisher & Paykel Healthcare; Boston (MA); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Employee share purchase scheme

Bi-annual Profit share

Life, Critical illness, and Income Protection Insurance

Discounted Health Insurance

Active Social clubs & community groups

In-house training programs

Purchasing privileges for company products

Banking and Insurance discounts

Free Parking

Beautiful campus with green spaces

Annual Salary Review

High rates of internal promotion

Access to state-of-the-art facilities

Job summary

A leading medical device company in Boston is seeking a Quality Engineer to collaborate with various teams and uphold quality standards. The ideal candidate should have over 3 years of experience in Quality Engineering, a tertiary qualification in Science or Engineering, and a solid understanding of relevant regulations. This full-time position offers significant career advancement opportunities in a supportive and inclusive culture, with various employee benefits including share purchase schemes and health insurance.

Qualifications

• 3+ years of work experience in Quality Engineering in the medical device industry.
• Working knowledge of standards and regulations like ISO13485.
• Experience with process and test method validation activities.

Responsibilities

• Collaborate with Operations, Production, and Process Development teams.
• Train and guide on quality standards for processes.
• Identify and implement improvements in the Quality Management System.

Skills

Quality Engineering

Communication Skills

Problem-Solving

Team Collaboration

Education

Tertiary qualification in Science or Engineering

Tools

ISO13485

ISO14971

21 CFR Part 820

MDR

Six Sigma or CQE certification

Job description

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

About The Opportunity

In this exciting role as a Quality Engineer – Manufacturing, you'll actively collaborate with Operations, Production, and Process Development teams. Your QMS and statistical knowledge will be key in providing training and guidance to uphold quality standards for both new and existing processes. Additionally, you will contribute to identifying and implementing improvements in our Quality Management System. A practical attitude, coupled with a willingness to collaborate, is crucial for success in this role, alongside a proactive nature and results-focused approach.

Offering involvement across every function of the business and exposure to a variety of products and manufacturing processes, this full-time position at our Auckland site will help you develop a strong understanding of the broader business. This sets the stage for an exciting array of career advancement options within F&P.

About You

• 3+ years of work experience in Quality Engineering in the medical device industry.
• A tertiary qualification in Science or Engineering.
• Working knowledge of standards and regulations (ISO13485, ISO14971, 21 CFR Part 820, MDR).
• Experience with process and test method validation activities.
• Working knowledge of statistics and process improvement tools.
• Six Sigma or CQE certification is preferable

You will also have:

• Excellent communication skills both written and verbal with the ability to share complex ideas, positively influence, negotiate, and challenge with tact and diplomacy.
• Strong problem-solving ability, (both through your own independent thinking and collaboration across the business) and a strong resilience when navigating problems.
• An ability to build relationships at all levels within the organization.

Working With Us

Care to join a supportive environment? Fisher & Paykel Healthcare foster an inclusive work environment founded on our culture of care and cooperation. Here you’ll have the trust and support to generate ideas, solve problems and do your best work.

• Employee share purchase scheme
• 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 and Medela products
• Banking and Insurance discounts
• Free Parking
• Beautiful campus with green spaces
• Annual Salary Review
• High rates of internal promotion
• Access to state-of-the-art facilities

About Us

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

Our commitment to care unites us. Here, we’re driven to improve patient care and outcomes through inspired and world-leading healthcare solutions.

Care to join us? Apply today

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.

We are dedicated to designing our recruitment process with care and empathy to support all candidates, regardless of identity, background, and experiences. Should you require support or adjustments during our process, please let us know at [e-mail].

This role is based in Auckland, New Zealand. Immigration/relocation support would be provided to the successful candidate.