The Operations team partners closely with ResMed’s 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.
Let’s talk about the role:
The Quality Assurance Engineer - Manufacturing will be partnering with multiples stakeholders to provide the quality and GMP governance and oversight to safeguard the quality and safety of ResMed products.
The Quality Assurance Engineer – Manufacturing plays a vital role to support and improve production quality and GMP compliance. As a subject matter expert, you will provide guidance for quality solutions on operational problems and issues at all levels.
Interfacing primarily with production teams, this role will ensure adherence to all elements of documentation and quality systems with the following responsibilities:
Ensure compliance with procedures in the ResMed quality system and determining/implementing ongoing improvements to the ResMed quality system
Analyse and report quality data on all aspects of manufacturing including actions for products under QA on-hold
Determine and process change requests, concessions, and the disposition of non-conforming items
Facilitate the closure of field complaints & out of box failures
Perform internal audits and assist with external quality system audits
Assist in the introduction of new manufacturing areas, product, equipment and processes.
Let’s talk about you:
At a minimum, the successful candidate will be a holder of a Bachelor Degree of Engineering with at least 5 years’ industrial experience preferably in a volume manufacturing in a highly regulated or medical industry.
You are naturally a critical thinker, problem solver and can easily adapt to the manufacturing systems. You are an excellent communicator and has proven track record in effectively liaising with different stakeholders.
Preference will be given to candidates who has good knowledge of FDA Quality System Regulations, GMP, and medical / pharmaceutical industry related ISO Standards.
Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s 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!