- 12 months Fixed Term Contract
- Location: Norwest, Sydney. Onsite parking facility available
- Work in a fast-paced environment with a supportive team.
The Opportunity
We are looking for a detail-oriented professional with a passion for quality assurance and compliance, to join us on a 12m fixed term contract basis. This role provides an excellent opportunity to expand your expertise in quality assurance, regulatory compliance, and internal audits while working on key compliance initiatives.
Reporting to the Senior Manager- Regulatory Affairs & Quality Assurance, in this key role as a QA Officer you will play a pivotal role in managing post-implementation review (PIR), complaint processes, post-market surveillance, recall administration, internal audits, and compliance program maintenance. Your contributions will support quality assurance (QA) and regulatory affairs (RA) projects aligned with regulatory requirements.
The Responsibilities
As a Quality Assurance Officer, you will be responsible for-
- Managing the complaints process in line with global product safety reporting requirements.
- Overseeing the feedback system, including investigation, reporting, and closure.
- Administering the Uniform Recall Procedure in case of product recalls.
- Developing and maintaining reporting dashboards for compliance tracking.
- Facilitating the Salesforce/PIR inboxes to ensure efficient communication.
- Participating in internal and external audits and assist in corrective/preventive actions (CA/PA).
- Maintaining BDOCS documentation and support WHS & environmental compliance.
- Ensuring compliance with ISO 9001, 13485, 45001, 14001 standards.
- Supporting cross-functional projects related to regulatory requirements.
- Staying updated with industry regulations and best practices through conferences and training.
The Requirements
To be successful in the role, you will have-
- Several years’ experience in a Quality Assurance role
- Strong knowledge of TGA and Medsafe regulations.
- Lead Auditor Qualification (preferred).
- Experience with ServiceMax, SAP MYA, DED, C3 is highly advantageous.
- Ability to interpret and apply regulatory legislation effectively.
- Exceptional attention to detail and solution-focused mindset.
- Strong project management skills with the ability to multitask.
- Excellent verbal and written communication for stakeholder engagement.
- Proficiency in Microsoft Office (Word, Advanced Excel), SAP.
Additional requirement :
To be eligible to apply, applicants must have full working rights in Australia, a valid Driver’s License and Passport, and be fully vaccinated against COVID-19.
Benefits
In return, you’ll have access to and benefit from:
- Flexible working conditions.
- Paid parental leave for both parents and community/volunteering leave.
- 17.5% annual leave loading.
- Tailored career development opportunities.
- Self-Care Day.
- Exclusive fitness and wellbeing programs.
- Novated Leasing
- Study Assistance Opportunities
- Financial Planning Support
- Recognition Programs
About Us
Operating since 1985, the B.Braun Australia Group is dedicated to advancing healthcare across Australia, New Zealand, and the Pacific Islands. Guided by our global mission to drive healthcare advancements through sharing expertise and the power of technology, we deliver innovative medical care solutions that make a meaningful difference in people’s lives.
With a team of approximately 300 skilled professionals and a growing portfolio of solutions, we contribute to health improvements in areas such as Infusion Therapy, Infection Control, Wound Management, Renal Services, Orthopaedics, and more.
Based in Norwest, Sydney, we are proud to be part of the B.Braun family—a global leader in medical technology with over 180 years of history and a presence in more than 60 countries. Together, we are transforming healthcare and empowering better health outcomes worldwide.
How to Apply
B.Braun Australia Group, a proud equal opportunity employer, is committed to fostering an inclusive, diverse, and vibrant workplace. We welcome applications from individuals of all backgrounds, including Aboriginal and Torres Strait Islander people, LGBTQI+ communities, people with disabilities, and those from culturally diverse backgrounds. Together, we aim to reflect and support the diverse customers and partners we serve.
To apply for this opportunity, please submit your resume along with a brief cover letter detailing your qualifications and interest in the role.
Upon receiving your application, our dedicated Talent Acquisition team will meticulously review your application. If you are shortlisted, you’ll be invited to engage in dynamic interviews, which may include phone calls, video chats, or in-person meetings. Throughout this process, we will keep you informed and engaged with regular updates and feedback.
Finally, if you are successful and decide to join us, we will lead you into our seamless onboarding experience.
Please note that relevant screening checks will be conducted as part of the recruitment process. These may include a National Criminal History check and Reference Checks.
Join us and be part of something extraordinary! For further information, please contact Manisha Khare at manisha.khare_ext@bbraun.com
B. BRAUN AUSTRALIA PTY. L | Manisha Khare |