Associate Quality Engineer

at  Fisher Paykel Healthcare

ABOUT YOU

Required skills and experience include:

• Experience in the medical device industry or equivalent.
• An understanding of FDA and international regulations and standards.
• A tertiary qualification in Science or Engineering.
• Experience in the following advantageous:
• Proficiency in statistics tools used for process validation, test method validation, and in-process monitoring (e.g., Cpk analysis, Gauge R&R, attribute analysis, AQL, SPC, DOE).
• Experience with risk management tools (pFMEA, dFMEA) and risk mitigation strategies.
• Strong background in process verification and validation and quality inspection activities.
• Excellent communication and influencing skills.
• Ability to build strong relationships across all organizational levels.

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.

Product innovation has been the cornerstone of our success since 1969, when our first prototype respiratory humidifier was developed. Today, our Respiratory Humidification (RH) products, (encompassing respiratory, infant care and anaesthetic products) continue to lead the way in delivering humidified air for our patients, ensuring the best of comfort and care.
We are thrilled to offer an exciting opportunity for an Associate Quality Engineer to join our Design Transfer Quality Team. 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).