Current jobs related to Raqa Specialist - Old Toongabbie - BAXTER

**This is where you save and sustain lives**

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

**The Role**

We have an exciting opportunity for a RAQA Specialist to join our RAQA team at Baxter. Reporting to the Regulatory Affairs and Quality Manager you will work collaboratively with the Operations, Quality and Supply Chain teams, enabling timely delivery of fully compliant products and processes as per the ANZ Commercial Business Plan.

With a key focus on Quality, your role will include working on effective management of the Quality Management Systems, management reviews, management of product complaints, nonconforming products, CAPA, internal audits, quality records control, training and supplier controls, in order to maintain certification to ISO9001. If you are a passionate quality professional looking to make a significant impact on patient lives, we’d love to hear from you

**This is where you can do your best work. Where your purpose accelerates our mission.**

**Key Responsibilities**:

- Proactively drive continuous improvement initiatives to ensure that the QMS remains relevant to continuing business growth and regulatory changes, and aligned to the Corporate QMS
- Work closely with the QA&RA Manager to create an environment of quality awareness and compliance across the organization
- Collaborate with Operations teams to ensure customer complaints are dealt with effectively, in a timely manner and in compliance to regulatory expectations
- Assist with the coordination of all Post marketing regulatory activities in ANZ including preparing submissions for TGA and Medafe responses, implementation and reporting of field actions to the regulators, and adverse event reporting
- Enable Product Return management
- Support safe working environment in accordance with the relevant Global policy on Occupational Health and Safety
- Actively promote Baxter mission, strategies, policies, procedures, and Code of Conduct.

**Key Requirements of the role include**:

- Tertiary degree in Science or related fields
- 5 years or more experience working in Quality and Regulatory environment within the Medical devices industry is desirable
- Good understanding and working knowledge of Australian and New
- Zealand medical device regulations and EU regulations
- Project management experience is highly regarded
- Highly developed interpersonal effectiveness and relationship-building abilities
- Collaborative approach and ability to work well with others.

**Why Baxter?**

At Baxter ANZ, we are focused on being a Best Place to Work where our people can be their authentic self, feel valued and respected. We are committed to a culture where all employees can collaborate and work together effectively. Relationships are a key component in how we operate in Baxter and we share the common traits of being reliable, ethical, caring, having empathy, actively listening to our colleagues as well as being open minded to new ideas and perspectives. Baxter is an organisation that makes inclusion and diversity a priority and that seeks to promote and improve gender equality in the workplace.

We are proud to be recognised among the top 120 companies for the seventh consecutive year as an Employer of Choice for Gender Equality for delivering support structures for working families; stronger actions to address pay inequalities; and strategic recruitment and promotion practices that help to encourage the full participation of women at work. We are also pleased to be the winner of the 2021 & 2019 Women in MedTech Champion Company Award.

Baxter recognises the importance of flexible work arrangements, and we offer part-time, flexible hours and work from home hybrid arrangements to support the balance of work and personal commitments. We are proud to introduce **BaxFlex,** where we maintain our workplace flexibility philosophy while also realising the benefits of connecting in-person on-site.

Situated in Western Sydney, and featuring and onsite cafeteria and café, gym, we offer a dynamic and future focused work environment offering workplace flexibility, development & career growth, volunteering leave, 12 weeks parental leave, income protection insurance and a strong value driven culture focused on diversity, equality, and inclusion.
- Baxter is an equal opportunity employer and makes employment