Job Description

The Operations team partners closely with ResMed\xe2\x80\x99s five business leaders to understand their needs then providing a variety of products and services to help them meet those needs including Customer and Technical Services, Global Quality Assurance and Regulatory Affairs, Supply Chain, manufacturing, logistics and distribution. Focused on enabling new product introduction and operating excellence, our team strives to improve time to market for new products and services, improve efficiencies in our cross-functional processes, and improve our supply chain through digitization and automation to increase value add to our customers.

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The primary role of Manufacturing Quality function is to design, implement and monitoring quality control programs. Key deliverables include, but not limited to, recommending changes to methods, procedures and standards to improve quality of output based on analysis of data and systems. Ensures products are built correctly to specification, quality standards and appropriate regulatory compliance. Reports defects and tracks until resolution.

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The primary objective of Supplier Quality Engineering specialization within Manufacturing Quality Job Family is to interface with development and supplier engineering to provide materials and components for company product manufacturing.

Communicates product specifications to suppliers and assesses supplier\xe2\x80\x99s ability to meet engineering and quality requirements.

Evaluates suppliers\xe2\x80\x99 internal functions to assess their overall performance and provides feedback in assessment of their operation.

Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.

Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.

Participate in supplier audits to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.

Performs work in a specialized area of expertise that requires knowledge of fundamental themes, principles and concepts. Typically requires a university degree or equivalent work experience.

Builds productive internal/external working relationships.

Occasionally leads the work of project teams and might formally train junior staff.

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Bachelor\xe2\x80\x99s degree in mechanical, mechatronics, biomedical, materials, chemical, or other closely related engineering field.

Minimum of 5 years of related experience.

Direct experience in supplier quality engineering, process development engineering, or manufacturing engineering for mechanical components or products.

Experience in the qualification, troubleshooting, and/or validation of injection moulding, LSR moulding, and/or CMSR processes.

Strong stakeholder management skills and ability to work with international suppliers. Some local and international travel may be required (typically
20%).

Strong understanding and application of root cause analysis tools with the ability to train and ensure suppliers utilize and follow standard methodology.

Working knowledge or exposure to medical device standards and regulations such as ISO 13485 and 21 CFR 820. Prior experience working in medical devices or another highly regulated industry is preferred.

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Joining us is more than saying \xe2\x80\x9cyes\xe2\x80\x9d to making the world a healthier place. It\xe2\x80\x99s discovering a career that\xe2\x80\x99s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now!

ResMed