Project Manager - Quality Assurance
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.
- 12 – month Fixed Term, Parental leave cover
- Located at Bella Vista
Let’s talk the responsibilities:
In this role, you will support the product owner on the QARA Scrum team, ensuring that projects from the QARA department are prioritised for upcoming product increments and work as part of the scrum team for successful completion of initiatives, including implementation in the business.
You will drive and lead major Corrective and Preventative Actions (CAPA) and provide support and guidance for both CAPA Tiers to regions as required, ensuring quality, efficiency and scalability of regional CAPA process meet the requirements of the business and external authorities (eg. ISO, MDSAP).
You will help ensure that ResMed’s products and the design and manufacturing operations comply with regulatory requirements such as, but not limited to, Food and Drug Administration FDA in the US, relevant competent authorities in Europe, and the Therapeutic Goods Administration (TGA) in Australia, ISO 13485 and Medical Device Single Audit Program (MDSAP).
The successful candidate will be performing the responsibilities, but not limited to, as below:
- To lead or coordinate CAPA and business process improvement projects that requires a high level of technical/process analysis skills.
- Mentor and assist CAPA Leaders to manage their CAPA’s and use the Continuous Improvement philosophy to bring about positive change
- Project manage the activities resulting from observations and non-conformances raised during internal audits by liaising with stakeholders and drive these findings to effective and timely closure
- Ensure that ResMed quality systems comply with the requirements and intent of the applicable regulatory standards
- Provide guidance to senior management with respect to project timing, resourcing, technical feasibility and costing and make recommendations that are in-line with overall company objectives
- Work with corresponding QA teams in other parts of ResMed ensuring that the audit systems are aligned to facilitate global deployment where appropriate
- Fostering a quality culture
Let’s talk about you:
At a minimum, the successful candidate will be a holder of a Bachelor Degree of Engineering or Science with at least 5 years’ audit experience in Quality or Project Management positions preferably in a highly regulated or medical industry.
To get us really excited, you will have formal training and experience in Project Management, including Agile and Scrum, and be knowledgeable of FDA and TGA regulatory requirements and experience in applicable international standards such as ISO 13485 and 21 CFR Part 820 requirements.
You are naturally a critical thinker, problem solver and an excellent communicator with proven track record in effectively liaising with different stakeholders.
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!
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