Quality Engineer - Manufacturing

Fisher & Paykel Healthcare; San Diego (CA); On-site; USD 53,000 - 68,000; Full time

Benefits offered by this job

Employee share purchase scheme

Profit sharing

Life, Critical illness and Income Pro‑

Discounted Health Insurance

Annual Salary Review

Internal promotion opportunities

State-of-the-art facilities

Job summary

Fisher & Paykel Healthcare is seeking a Quality Engineer – Manufacturing to collaborate with Operations, Production and Process Development teams. You will apply QMS knowledge to uphold quality standards and drive improvements across processes.

The role offers exposure to a variety of products and manufacturing processes within our Auckland site, with career advancement opportunities across the business.

Qualifications

• 3+ years of work experience in Quality Engineering in the medical device industry.
• Tertiary qualification in Science or Engineering.
• Working knowledge of ISO13485, ISO14971, 21 CFR Part 820, MDR.

Responsibilities

• Collaborate with Operations, Production, and Process Development teams to uphold quality standards.
• Provide training and guidance on the QMS and quality systems.
• Identify and implement improvements in the Quality Management System.

Skills

Quality engineering

Statistical methods

Process validation

Regulatory standards

Six Sigma / CQE (preferred)

Communication skills

Problem solving

Relationship building

Education

Bachelors degree in Science or Engineering

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.