We are proudly a certified Great Place to Work companyRole with direct impact on NZ healthcareTraining and development support within highly professional teamWHY BUNZL?As part of the Bunzl Group, Obex Medical specialises in the supply of minimally invasive, consumable, and implantable devices which enable the delivery of the best diagnosis and therapy for patients. As an industry leader, we provide high level clinical and technical expertise to the New Zealand healthcare sector. Ours is a culture of bringing out the best in people. And we do this with a strong entrepreneurial spirit, a firm commitment to training and development, and dedicated leaders who believe that every day is a new day to see new opportunities.YOUR ROLEAs a Quality Lead, you will coordinate Obex's compliance to regulatory requirements and ensure robust quality systems in accordance with ISO standards and the company's expectations and objectives.Your main responsibilities will include the following:Provide regulatory leadership to ensure adherence to compliance related standards and the smooth running of regulatory activitiesWork with sales and marketing team to advance Supplier relationships and continue to grow Obex regulatory reputation in marketEnsure compliance with NZ sponsor responsibilities for medical devices and medicinesCoordinate the administration of Promapp to optimise the functionality and to ensure robust company processesManage the pharmacovigilance process and MOH audits as required. Coordinate new and existing staff training in pharmacovigilanceManage the renewal of dangerous goods safety datasheets with external consultantManage the ISO Quality systems to ensure continued compliance with ISO9001 and ISO45001 standardsABOUT YOUUnderstanding of NZ device regulatory environmentExperience training or coaching team membersUnderstanding and experience in ISO and quality systemsExperience using Promapp (or similar process mapping tool)Familiarity with regulatory frameworksBENEFITSBunzl offers a broad and flexible range of benefits to our team including profit share scheme for eligible employees, exclusive motor vehicle and health insurance products, travel and accommodation discounts, study assistance, many wellbeing and community programs and access to discounted Bunzl products.WE BELIEVEWith an entrepreneurial spirit providing endless opportunities, we believe that together we can achieve anything. We believe that through diversity we build strength and stability, and that the safety and security of our employees is not negotiable. Through innovation we find solutions, with an entrepreneurial spirit providing endless opportunities, and we believe that together we can achieve anything. Investing in our local communities is the right thing to do, and here in APAC that investment is creating a sustainable environment for us and those who follow.WE WELCOME ALLAt Bunzl we believe that through diversity we build strength and support the principle of equality and diversity in employment. We oppose all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships. We believe that it is in the company's best interests and those of all who work in it, to ensure that the human resources, talents and skills available throughout the community are considered when employment opportunities arise. If you have a disability or special need that requires support or adjustments to working or interview arrangements, please let us know.APPLYAt Bunzl, we believe that when you join our team, your potential is endless. Because at Bunzl… We believe in you! If you like the sound of this, then we definitely want you on our team.We are a Circle Back Platinum Employer – we commit to respond to every applicant.#J-18808-Ljbffr
