Senior Quality Specialist, Technical Services
- Old Toongabbie, NSW
- Permanent
- Full-time
We are seeking a Senior Quality Specialist to join our Technical Services team at Baxter. As a key member of our team, you will play a critical role in ensuring processes and procedures for Technical Service Operations in Australia and New Zealand are in compliance to regulatory requirements and in line with Corporate Quality Manual and Global Service requirements.You will actively participate in the design, implementation and/or maintenance of the quality processes in the field service (technical) operations and service center operations, while maintaining a strong relationship with the Global Services team , and relevant stakeholders across the broader Baxter business.This role will be based at our Old Toongabbie office with time spent at the Technical Services Depot.ResponsibilitiesProvide quality support to field service operations in Australia and New ZealandOffer quality support to service center operations in these regionsServe as the Local Process Owner for Global Services Quality Systems in Australia and New Zealand, including documentation, procedures, training, internal and external audits, CAPA, non-conformities, and post-marketing surveillance activitiesCoordinate supplier qualification, validation processes (IQ, OQ, PQ protocols), change control processes, and risk assessmentsEnsure compliance in processes such as device release, labeling, storage areas, calibration, decontamination, equipment validations, repair, PM, and spare parts managementMonitor and act on quality critical metrics using TS systemsAct as the Local QMR for Technical Service in Australia and New ZealandSupport and/or lead local or regional Service QA and Operational projects and initiatives as required.Key RequirementsTertiary degree in Science/Biomedical Engineering or related fieldsProven experience in quality assurance within a technical services environmentStrong understanding of regulatory requirements and quality systems in Australia and New ZealandPrior experience within Medical Devices or Medical Capital is highly desirableOutstanding communication and collaboration skillsAbility to successfully implement quality processes and proceduresProven track record of managing and leading projects to a flawless conclusion.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.Baxter is proud to be recognized as an Inclusive Employer by the Diversity Council of Australia. We are also committed to 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 all people at work.Baxter is an equal opportunity employer and makes employment decisions without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status, or any other status protected by law. Baxter encourages applicants of all ages.#li-baxgen#LI-JB1#ind-anzEqual Employment OpportunityBaxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.Reasonable AccommodationsBaxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the here and let us know the nature of your request along with your contact information.Recruitment Fraud NoticeBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our .