Sydney, New South Wales, Australia
Onsite
The primary role of Post Market Quality team is to be responsible for all post-market quality activities. Key deliverables include systems and processes, complaint management systems and associated reporting. Development of software service tools, manuals, service portals, and parts and components for post market service activities. Engineering investigations for field product failures. Works closely with R&D on any suggested design changes and reports defects and tracks until resolution.
Let’s talk about Responsibilities
The primary objective of this role as a Graduate Engineer is to assess patient risk, inspecting, testing and evaluating the returned devices from the field and escalating new issues when required as part of the investigation process.
Applying engineering techniques to investigate root cause of product issues.
Writing protocols and reports as part of the investigation process.
Review field data to identify trends and recommend actions when necessary.
Assuring compliance to in-house and/or external specifications and standards (i.e. GMP and ISO standards).
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.
Perform all quality system and process actions as directed.
Document all activities and generate appropriate reports for internal and external use.
Communicate with external and internal stakeholders.
Perform Data analytics to provide insights such as Product Field Performance (PFP) or Field occurrences and present data to stakeholders for risk assessment and decision making.
Self-management of tasks by the individual and directed by the QA Manager - Investigations and/or mentor(s) with minimum supervision.
Operate with a high level of autonomy whilst interacting effectively with, and seeking input from Product Development (PD), Product Lifecycle Engineering (PLE) team members and other areas of the business including marketing, manufacturing, clinical and regulatory affairs.
Let’s talk about Qualifications and Experience Required:
Bachelor’s degree (Engineering - Electrical/Electronics/Mechatronics or equivalent)
Preferred:
Medical device experience, particularly with flow generator or ventilator products.
Good experience in troubleshooting electro-mechanical devices, system issues, etc.
Good working experience in a regulated environment and/or experience in Product Development/R&D.
Ability to use CAD tools, such as Altium Designer 6.
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! We commit to respond to every applicant.
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