Overview
An exciting opportunity for you to build and develop your engineering expertise while providing interesting and challenging solutions.
Are you results – focused with a passion for problem-solving and innovation? This role will allow you to tap into your drive, initiative and creativity.
Reporting to the Manager, Quality Engineering, you will join a diverse group of experienced QA professionals to serve as the lead quality representative for Cook Australia products within the production lifecycle phase.
Our culture is inclusive and we treat everyone with respect. For us that means we are open to and value different ideas and perspectives and are appreciative of each person's contributions.
Responsibilities
* Provide ongoing support to the quality management system (QMS) in line with ISO 13485 and FDA's 21 CFR Part 820
* Perform activities within the QMS to ensure company quality objectives are achieved
* Lead and support the management of product/process non-conformances, including root cause analysis, risk assessment, escalation, disposition and identification of corrective actions
* Conduct risk-based decision making and effective resolution of issues which impact on production
* Facilitate, lead and collaborate with cross functional teams to improve QMS and manufacturing processes
* Provide quality support for change management including the review and approval of changes to medical device design, labelling, manufacturing, facilities, equipment, software and quality system processes
* Support the Corrective and Preventative Actions (CAPA) process as a CAPA assignee or CAPA sponsor
* Identify continuous improvement initiatives
Qualifications
* Tertiary qualification in a technically related field i.e. Science or Engineering essential
* Working knowledge of investigation methods and tools preferred
* Experience working within a highly regulated industry such as Medical Devices essential
* Knowledge of medical device regulations, including pertinent standards and guidance essential
* An understanding of quality control/assurance in a manufacturing environment essential
Employee Benefits:
* Base salary plus performance-based quarterly bonus and annual leave loading
* Prioritise your physical and mental wellbeing with access to onsite gym and our employee assistance program
* Subsidised cafeteria, wellness room and prayer room
About us:
Since 1963, Cook Medical have been inventing, manufacturing and delivering a unique portfolio of medical devices to healthcare systems around the world. We work closely with physicians to develop technologies that improve patients' lives. Because we remain family owned, we have the freedom to focus on what we care about: patients, our employees and our communities.
At Cook Medical, we use our high ethical standards and core values to guide our decisions and actions. We approach innovation by first listening to understand and then creating a solution.
Supporting a Diverse Workforce:
We are proud of our diverse workforce and value individual contribution. We appreciate that every employee can add value to our organisation in their own unique way and want to ensure that our company culture stays balanced and strong.
We encourage applications from Indigenous Australians, people with disability, those from diverse cultural backgrounds, people from the LGBTQI+ community, and anyone else who wants to be a part of our Cook Australia family.
Community Commitment:
Our community program seeks to have a positive, transforming impact on our people, the environment and our local community. The program has four pillars:
* Community Engagement: We support our local community through philanthropy, education and partnerships. Our employees have been at the forefront of these initiatives, and we're proud of their contribution to making our community stronger.
* Environment and Sustainability: We are committed to being good stewards of the environment by aiming to ensure that our practices and processes are sustainable and responsible.
* Employee Engagement: We invest in our internal community through developing our employees, supporting their wellbeing and promoting an inclusive and diverse culture.
* Reconciliation: We're exploring a pathway towards making a meaningful commitment to Reconciliation by strengthening our understanding and appreciation of Aboriginal and Torres Strait Islander peoples' cultures, history and diversity.
Learn more about us:
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